ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR- salicylic acid gel

ELF ACNE Fighting Spot Gel with Aloe Clear by

Drug Labeling and Warnings

ELF ACNE Fighting Spot Gel with Aloe Clear by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc, Zhejiang Ayan Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Salicylic Acid 1.0 %

PURPOSE

Purpose:

Acne Treatment

INDICATIONS & USAGE

Uses:

For the treatment of acne

Helps prevent new acne blemishes

WARNINGS

Warning:

For external use only

WHEN USING

When Using This Product:

Keep out of eyes, rinse with water to remove.

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

ASK DOCTOR

Stop use and ask a doctor If

rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

DOSAGE & ADMINISTRATION

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 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.

STORAGE AND HANDLING

Other Information:

Protect the product in this container from exessive heat and direct sun

INACTIVE INGREDIENT

Inactive Ingredient:

Water,  Alcohol Denat, Hamamelis Birginiana (Witch Hazel), Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cinnamomum Camphora (Camphor) Bark oil, Sodium Benzoate, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Camellia Sinensis Leaf Extract, Butylene Glycol, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Ethylhexylglycerin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR OIL (UNII: 75IZZ8Y727)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TEA TREE OIL (UNII: VIF565UC2G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WITCH HAZEL (UNII: 101I4J0U34)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-616-01	6 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/20/2015

Labeler - J. A. Cosmetics U.S. INC (186705047)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co., Ltd.		544377996	manufacture(76354-616)