Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Use

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.

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

Inactive ingredients

Water (aqua), pentylene glycol, biberry (Vaccinium myrtilus) fruit extract, xanthan gum, sodium hydroxide, sugarcane (Saccharum officinarum) extract, glycerin, saccharide isomerate, orange (Citrus sinensis) fruit extract, lemon (Citrus x limon) fruit extract, sugar maple (Acer saccharum) extract, hydrolyzed algin, citric acid, sodium citrate, zinc sulfate.

Package Labeling:

Outer Package Inner Package

ACNE TREATMENT GEL
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:31720-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MYRICA CERIFERA FRUIT (UNII: 2VZ27D14UH)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUGARCANE (UNII: 81H2R5AOH3)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
ORANGE (UNII: 5EVU04N5QU)
LEMON (UNII: 24RS0A988O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ZINC SULFATE (UNII: 89DS0H96TB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:31720-301-08	1 in 1 BOX	12/05/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	12/05/2022

Labeler - S+ (572406531)