Drug Facts

Active ingredients

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

for the treatment of acne.

Warnings

For external use only.

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time • if irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

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

If contact occurs, flush thoroughly with water. Avoid contact with eyes.

Directions

• clean the skin thoroughly before applying this product • cover the entire affected area with a thin layer one to three times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

Avoid storing at extreme temperatures (below 40°F and above 100°F).

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Stearic Acid, Cetearyl Alcohol, Colloidal Sulfur, Glycerin, Succinic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Benzyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Ethylhexylglycerin, Sodium Hydroxide, Dehydroacetic Acid, Malachite Extract, Sorbitan Isostearate, Trisodium Ethylenediamine Disuccinate, CI 75810 (Chlorophyllin-Copper Complex).

Questions or Comments?

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Package Labeling:

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THE INKEY LIST SUCCINIC ACID ACNE TREATMENT
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81136-017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SULFUR (UNII: 70FD1KFU70)
GLYCERIN (UNII: PDC6A3C0OX)
SUCCINIC ACID (UNII: AB6MNQ6J6L)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SQUALANE (UNII: GW89575KF9)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81136-017-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	12/01/2020

Labeler - Brand Evangelists for Beauty Ltd (222990724)

THE INKEY LIST- SUCCINIC ACID ACNE TREATMENT