Acne Spot Treatment by e.l.f. Cosmetics, Inc Acne Spot Treatment

Acne Spot Treatment by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACNE SPOT TREATMENT- salicylic acid liquid 
e.l.f. Cosmetics, Inc

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Acne Spot Treatment

Drug Facts

Active ingredients

Salicylic Acid 1.8%

Purpose

Acne Treatment

Uses

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

Warnings

For external use only.

• Keep out of eyes. Rinse with water to remove.
• 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.

Stop use and ask a doctor if

rash occurs.

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 neede or a directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water (Aqua), Alcohol Denat., PPg-26-Buteth-26, Aloe Barbadensis Leaf Juice, Niacinamide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylate Crosspolymer-6, PEG-40 Hydrogenated Castor Oil, Acacia Seneggl Gum, Salix Alba (Willow) Bark Extract, Zinc PCA, Dipotassium Glycyrrhizate, Portulaca Oleracea Extract, Propanediol, Caprylyl glycol, Ethylhexylglycerin, Phenoxyethanol, Citric acid, Limonene

Questions or comments?

1-888-315-9814

Package Labeling:

ACNE SPOT TREATMENT 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	18 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PURSLANE (UNII: M6S840WXG5)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
NIACINAMIDE (UNII: 25X51I8RD4)
TEA TREE OIL (UNII: VIF565UC2G)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
ACACIA (UNII: 5C5403N26O)
SALIX ALBA BARK (UNII: 205MXS71H7)
ZINC PIDOLATE (UNII: C32PQ86DH4)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-413-15	1 in 1 BOX	09/01/2021
1		15 mL in 1 BOTTLE; 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	09/01/2021	11/06/2024

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

Revised: 11/2024

Document Id: 26416a04-2911-80cd-e063-6394a90abc9a

34390-5

Set id: c716ab24-4ee0-197a-e053-2995a90a3a99

Version: 5

Effective Time: 20241106