Breakout Clearing Emergency Spot Fix

Manufacturer: Dermalogica, Inc. | Cosway | Diamond Wipes
Effective date: 2014-02-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:38:25

Label at a glance#

ProductBreakout Clearing Emergency Spot Fix

Active ingredientBenzoyl Peroxide

Label structure10 sections

Dosage and administration

Cleanse the skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 times a day. Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, use a sunscreen. Allow Eme...

Storage and handling

Protect this product from excessive heat and direct sun.

Contacts and useful links#

PhoneLabel contact1-800-831-5150

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide (5.0%)

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

In or near eyes
On broken skin
On lips or large areas of the body
If you have very sensitive skin
If you are sensitive to benzoyl peroxide

Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

When using this product

OTC - WHEN USING SECTION

Apply to affected areas only.
Avoid unnecessary sun exposure and use sunscreen.
This product may bleach hair or dyed fabrics.
Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.

Stop use and ask a physician

OTC - STOP USE SECTION

If too much skin irritation or sensitivity develops or increases.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse the skin thoroughly before applying.
Cover the affected area with a thin layer 1 to 3 times a day.
Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
If going outside, use a sunscreen. Allow Emergency Spot Fix to dry, then follow directions of the sunscreen labeling.
If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, PEG-8, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Enantia Chlorantha Bark Extract, Oleanolic Acid, Lavandula Angustifolia (Lavender) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Spiraea Ulmaria Extract, Cetyl Alcohol, Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Polysorbate 80, Glyceryl Stearate, Caprylic/Capric Triglyceride, Ethylhexylglycerin, Butylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Xanthan Gum, Disodium EDTA, Phenoxyethanol.

Questions or comments

OTC - QUESTIONS SECTION

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 9 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermalogica^®
clear

5%
benzoyl
peroxide

Breakout Clearing
Emergency
Spot Fix

0.3 US FL OZ / 9 mL e

Principal Display Panel - 9 mL Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
106309	benzoyl peroxide 5 % Topical Lotion	PSN	1
1489215	Clear Start Emergency Spot Fix 5 % Topical Lotion	PSN	1
1489215	benzoyl peroxide 50 MG/ML Topical Lotion [Clear Start Emergency Spot Fix]	SBD	1
106309	benzoyl peroxide 50 MG/ML Topical Lotion	SCD	1
106309	benzoyl peroxide 5 % Topical Lotion	SY	1
1489215	Clear Start Emergency Spot Fix 5 % Topical Lotion	SY	1
1489215	Dermalogica Clear Start Breakout Clearing 5 % Topical Lotion	SY	1
1489215	Dermalogica Emergency Spot Fix 5 % Topical Lotion	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68479-202-00	2020-01-31	C162847	48780-1	9d75b9d0-4a20-f424-e053-dadaa90a57ce	Breakout Clearing Emergency Spot Fix
68479-202-02	2020-01-31	C162847	48780-1	9d75b9d0-4a20-f424-e053-dadaa90a57ce	Breakout Clearing Emergency Spot Fix

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68479-202-00	Breakout Clearing Emergency Spot Fix	2 mL in 1 POUCH	LOTION	2	1
68479-202-02	Breakout Clearing Emergency Spot Fix	1 in 1 CARTON	LOTION	1	1
68479-202-02	Breakout Clearing Emergency Spot Fix	9 mL in 1 TUBE	LOTION	9	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68479-202	BREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	1	Legacy NDC, 3 package rows	20140215_f1db1790-822e-41b3-af4d-1e28387c090d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzoyl Peroxide	ACTIVE INGREDIENT	W9WZN9A0GM	1
Benzoyl Peroxide	ACTIVE MOIETY	W9WZN9A0GM	1
Aminomethylpropanol	INACTIVE INGREDIENT	LU49E6626Q	1
Annickia Chlorantha Bark	INACTIVE INGREDIENT	H70115MP4A	1
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked)	INACTIVE INGREDIENT	59TL3WG5CO	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	1
Filipendula Ulmaria Root	INACTIVE INGREDIENT	997724QNDS	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
Glycyrrhiza Glabra	INACTIVE INGREDIENT	2788Z9758H	1
Green Tea Leaf	INACTIVE INGREDIENT	W2ZU1RY8B0	1
Lavandula Angustifolia Flowering Top	INACTIVE INGREDIENT	9YT4B71U8P	1
Medium-Chain Triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	1
Oleanolic Acid	INACTIVE INGREDIENT	6SMK8R7TGJ	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
Porphyra Umbilicalis	INACTIVE INGREDIENT	14AN0J70WO	1
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW)	INACTIVE INGREDIENT	1DXE3F3OZX	1
Tea Tree Oil	INACTIVE INGREDIENT	VIF565UC2G	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

Breakout Clearing Emergency Spot Fix
Benzoyl Peroxide
Water
Polyethylene Glycol 400
Green Tea Leaf
Glycyrrhiza Glabra
Porphyra Umbilicalis
Annickia Chlorantha Bark
Oleanolic Acid
Lavandula Angustifolia Flowering Top
Tea Tree Oil
Filipendula Ulmaria Root
Cetyl Alcohol
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW)
Polysorbate 80
Glyceryl Monostearate
Medium-Chain Triglycerides
Ethylhexylglycerin
Butylene Glycol
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked)
Aminomethylpropanol
Xanthan Gum
Edetate Disodium
Phenoxyethanol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68479-202	68479-202-02, 68479-202-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Benzoyl Peroxide	W9WZN9A0GM	ACTIB
Water	059QF0KO0R	IACT
Polyethylene Glycol 400	B697894SGQ	IACT
Green Tea Leaf	W2ZU1RY8B0	IACT
Glycyrrhiza Glabra	2788Z9758H	IACT
Porphyra Umbilicalis	14AN0J70WO	IACT
Annickia Chlorantha Bark	H70115MP4A	IACT
Oleanolic Acid	6SMK8R7TGJ	IACT
Lavandula Angustifolia Flowering Top	9YT4B71U8P	IACT
Tea Tree Oil	VIF565UC2G	IACT
Filipendula Ulmaria Root	997724QNDS	IACT
Cetyl Alcohol	936JST6JCN	IACT
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW)	1DXE3F3OZX	IACT
Polysorbate 80	6OZP39ZG8H	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
Medium-Chain Triglycerides	C9H2L21V7U	IACT
Ethylhexylglycerin	147D247K3P	IACT
Butylene Glycol	3XUS85K0RA	IACT
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked)	59TL3WG5CO	IACT
Aminomethylpropanol	LU49E6626Q	IACT
Xanthan Gum	TTV12P4NEE	IACT
Edetate Disodium	7FLD91C86K	IACT
Phenoxyethanol	HIE492ZZ3T	IACT

Source Document#

Source XML · Source PDF

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 5 · 289 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / RECTAL	0.25 mg/mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		4739 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / OPHTHALMIC		26 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Medium-Chain Triglycerides	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY / TOPICAL		540 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		34 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Medium-Chain Triglycerides	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii candidate 18 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
Medium-Chain Triglycerides	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, EXTENDED RELEASE / ORAL	0.37 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, LIQUID FILLED / ORAL		24 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / AURICULAR (OTIC)		13 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates

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
a428575c-cefa-4f1d-8712-faf36371ae8c			f1db1790-822e-41b3-af4d-1e28387c090d	2014-02-05	Warnings	Exact identifier spl id: a428575c-cefa-4f1d-8712-faf36371ae8c spl set id: f1db1790-822e-41b3-af4d-1e28387c090d

Reported adverse events (FAERS/openFDA)#

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