ACNE FIGHTING SPOT GEL- salicylic acid gel

Acne Fighting Spot Gel by

Drug Labeling and Warnings

Acne Fighting Spot Gel by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

• For the treatment of acne
• Helps prevent new acne blemishes

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

Cleanse the skin thoroughly before applying medication. 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. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Water (Aqua), Alcohol Denat., Butylene Glycol, Polyacrylate Crosspolymer-6, Camphor, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hamamelis Virginiana (Witch Hazel) Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, T-Butyl Alcohol, Sodium Benzoate, Phenoxyethanol, Denatonium Benzoate

Questions or comments

1-888-315-9814

Package Labeling:

INGREDIENTS AND APPEARANCE

ACNE FIGHTING SPOT GEL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-414
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TEA TREE OIL (UNII: VIF565UC2G)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-414-01	1 in 1 CARTON	02/25/2022
1		7.5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/25/2022

Labeler - e.l.f. Cosmetics, Inc (093902816)