Acne Treatment Clear Gel - Maximum Strength

Manufacturer: McCure Health Solutions Inc. | Jiangsu Dedi Medical Device Co., Ltd..
Effective date: 2016-12-28
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:48:16

Label at a glance#

ProductAcne Treatment Clear Gel - Maximum Strength

Active ingredientSALICYLIC ACID

Label structure7 sections

Indications and uses

for the treatment and prevention of acne pimples

Dosage and administration

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times day. Use to prevent new pimples from forming.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

for the treatment and prevention of acne pimples

Warnings

WARNINGS SECTION

for external use only.

do not use

OTC - DO NOT USE SECTION

if you have sensitive skin or are sensitive to Salicylic Acid.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes, lips and mouth.

if using with other topical acne medications, at the same time or immediately following use of this product, increased dryness of the skin may occur. If this occurs, only one medication should be used unless otherwise directed by a doctor. Skin irritation may occur characterized by redness, burning, itching, peeling or possible swelling. Mild irriation may be reduced by using this product less frequently or lower concentration. Stop use and ask a doctor if skin irritation becomes severe.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times day. Use to prevent new pimples from forming.

Other information

SPL UNCLASSIFIED SECTION

store at 15 - 30 C (59 - 86 F)
close cap tightly after use
do not use if seal on tube is punctured or missing
keep away from heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

DMDM HYDANTOIN, GLYCERIN, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL, WATER

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACNE TREATMENT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
252296	salicylic acid 0.5 % Topical Gel	PSN	4
252296	salicylic acid 0.005 MG/MG Topical Gel	SCD	4
252296	salicylic acid 0.5 % Topical Gel	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52486-010-28	2020-01-31	C162847	48780-1	9d75b9d0-f4d8-f424-e053-dadaa90a57ce	Acne Treatment Clear Gel - Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52486-010-28	Acne Treatment Clear Gel - Maximum Strength	28 g in 1 TUBE	GEL	28		4
52486-010-28	Acne Treatment Clear Gel - Maximum Strength	1 in 1 CARTON	GEL	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52486-010	ACNE TREATMENT CLEAR GEL - MAXIMUM STRENGTH (SALICYLIC ACID) GEL [MCCURE HEALTH SOLUTIONS INC.]	4	Legacy NDC, 2 package rows	20161228_b6d663c4-c488-463c-babf-c32fe9ea024b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	3
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Acne Treatment Clear Gel - Maximum Strength
SALICYLIC ACID
DMDM HYDANTOIN
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52486-010	52486-010-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DMDM HYDANTOIN	BYR0546TOW	IACT
GLYCERIN	PDC6A3C0OX	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SALICYLIC ACID	O414PZ4LPZ	ACTIB

Source Document#

Source XML

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 6 · 304 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 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
44bd9411-0c34-1729-e054-00144ff88e88			b6d663c4-c488-463c-babf-c32fe9ea024b	2016-12-28	Warnings	Exact identifier spl id: 44bd9411-0c34-1729-e054-00144ff88e88 spl set id: b6d663c4-c488-463c-babf-c32fe9ea024b

Reported adverse events (FAERS/openFDA)#

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