Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)

Manufacturer: Padagis Israel Pharmaceuticals Ltd
Effective date: 2023-04-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-05-31 22:02:29

Label at a glance#

ProductSulfacetamide Sodium

Active ingredientSULFACETAMIDE SODIUM

Label structure13 sections

Dosage and administration

Apply a thin film to affected areas twice daily.

Storage and handling

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Shake well before using. Keep tightly closed.

Contacts and useful links#

Websitewww.padagis.com

www.padagis.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION

DESCRIPTION SECTION

Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains 100 mg of sulfacetamide sodium in a vehicle consisting of diethanolamine; EDTA; hydroxyethyl cellulose; lauramide DEA; methylparaben; polyethylene glycol 400, monolaurate; propylene glycol; purified water; simethicone; sodium chloride; sodium metabisulfite and xanthan gum.

Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically, sulfacetamide sodium is N'-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of paraminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

The pharmacokinetics of sulfacetamide and its major metabolite sulfanilamide in sulfacetamide sodium lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied sulfacetamide sodium lotion to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of sulfacetamide sodium lotion excreted in the urine as sulfacetamide plus sulfanilamide ranged from 0.08 to 0.33%.

INDICATIONS

INDICATIONS & USAGE SECTION

Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated in the topical treatment of acne vulgaris.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

WARNINGS

WARNINGS SECTION

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).

PRECAUTIONS

PRECAUTIONS SECTION

General -

GENERAL PRECAUTIONS SECTION

For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects: Pregnancy Category C - Animal reproduction studies have not been conducted with Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) should be given to a pregnant woman only if clearly needed.

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers -

NURSING MOTHERS SECTION

It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use -

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of sulfacetamide sodium lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with sulfacetamide sodium lotion had adverse reactions of erythema, itching and edema. It has been reported that sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply a thin film to affected areas twice daily.

HOW SUPPLIED

HOW SUPPLIED SECTION

Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is available as follows:

4 FL OZ (118mL) bottles (NDC 45802-896-26)

STORAGE

STORAGE AND HANDLING SECTION

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Shake well before using. Keep tightly closed.

SPL UNCLASSIFIED SECTION

Manufactured by Padagis^®
Yeruham, Israel

www.padagis.com

Rev 04-23

34S26 RC F4

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45802-896-26

Rx Only

Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)

For Topical Use Only

Shake Well Before Using

4 FL OZ

(118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1006688	sulfacetamide sodium 10 % Topical Lotion	PSN	12
1006688	sulfacetamide sodium 100 MG/ML Topical Lotion	SCD	12
1006688	sulfacetamide sodium 10 % Topical Lotion	SY	12
1006688	sulfacetamide sodium 10 % Topical Suspension	SY	12

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
SULFACETAMIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
0304b7d2-7a07-d53b-750f-36012ae6612e	Product name	1	20140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-896-26	Sulfacetamide Sodium	118 mL in 1 BOTTLE, PLASTIC	LOTION	118		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-896-26	ML - Milliliter	45802-896	d8ea719a-62c7-4f74-bcf6-5584e4a8260d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SULFACETAMIDE SODIUM	ACTIVE INGREDIENT	4NRT660KJQ	4
SULFACETAMIDE	ACTIVE MOIETY	4965G3J0F5	4
DIETHANOLAMINE	INACTIVE INGREDIENT	AZE05TDV2V	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	4
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	4
LAURIC DIETHANOLAMIDE	INACTIVE INGREDIENT	I29I2VHG38	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Sulfacetamide Sodium
SULFACETAMIDE
DIETHANOLAMINE
EDETIC ACID
LAURIC DIETHANOLAMIDE
METHYLPARABEN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
WATER
SODIUM CHLORIDE
SODIUM METABISULFITE
XANTHAN GUM
DIMETHICONE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
45802-896	45802-896-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SULFACETAMIDE SODIUM	4NRT660KJQ	ACTIB
DIETHANOLAMINE	AZE05TDV2V	IACT
EDETIC ACID	9G34HU7RV0	IACT
LAURIC DIETHANOLAMIDE	I29I2VHG38	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
XANTHAN GUM	TTV12P4NEE	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
11	2023-04-01	full-release	2026-05-31 21:01:24

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
LAURIC DIETHANOLAMIDE	LAURIC DIETHANOLAMIDE	I29I2VHG38	LOTION / TOPICAL	0.6 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route 2 equally ranked IID candidates
LAURIC DIETHANOLAMIDE	LAURIC DIETHANOLAMIDE	I29I2VHG38	LOTION / TOPICAL	0.6 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route 2 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DIETHANOLAMINE	DIETHANOLAMINE	AZE05TDV2V	CREAM / TOPICAL	0.3 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	LOTION / TOPICAL	0.2 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUSPENSION / TOPICAL	0.06 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
DIETHANOLAMINE	DIETHANOLAMINE	AZE05TDV2V	CREAM / TOPICAL	0.3 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SOLUTION / TOPICAL	0.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SOLUTION / TOPICAL	0.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	LOTION / TOPICAL	0.2 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUSPENSION / TOPICAL	0.06 %w/v		Exact identifier — unii+route 10 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078649-001	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB		2009-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078649-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078649-001	SULFACETAMIDE SODIUM	10%	LOTION / TOPICAL	AB	2009-03-23	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078649-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078649-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078649-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078649-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078649-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078649-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078649-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078649-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078649-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078649-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078649-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078649-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078649-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078649-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078649-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078649-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078649-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078649-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078649-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078649-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078649-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078649-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078649-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078649-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078649-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078649-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078649-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078649-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078649-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078649-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078649-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078649-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078649-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078649-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078649-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078649-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078649-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078649-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078649-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078649-001	AB	1	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Padagis Israel Pharmaceuticals Ltd	4fb4d39a-330e-4c84-abbc-3b33b36b206f	2023-04-01	Warnings, Adverse reactions	Exact identifier ndc (package): 45802-896-26 ndc (product): 45802-896 ndc11 (package): 45802089626 spl id: 03f16a28-7c10-4fa0-a4c8-ac29335c6be7 spl set id: 4fb4d39a-330e-4c84-abbc-3b33b36b206f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)

Label at a glance#

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General -

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Pregnancy

Nursing Mothers -

Pediatric Use -

ADVERSE REACTIONS

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

STORAGE

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Older Hydrated Versions#

Inactive ingredient matches#

Orange Book application contexts#

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#