DERMACLEAR BHA CLEANSER- salicylic acid lotion

DermaClear BHA Cleanser by

Drug Labeling and Warnings

DermaClear BHA Cleanser by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Salicylic Acid 2%

PURPOSE

Purpose: Acne Treatment

INDICATIONS & USAGE

Uses - Fot the treatment of acne

DO NOT USE

Do not use if you - have very sensitive skin

WHEN USING

When using this product -

• Avoid contact with the eyes, lips and mouth
• Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
• If sensitive to the sun or when increased sun exposure is expected use a sunscreen

STOP USE

Stop use and ask a doctor -

• if severe skin irritation occurs
• Using other topical medication at the same time

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed , get medical help or contact a Poison Cotrol Center right away.

DOSAGE & ADMINISTRATION

Directions - Emulsify cleanser with lukewarm water and gently massage onto the skin, avoiding the eye area. Rinse well and pat dry. Not recommended for those with asprin / NASID allergies.

INACTIVE INGREDIENT

Inactive Ingredients -

Water (Aqua), Sorbitol, Cetyl Alcohol, Stearyl Alcohol, PPG12/'SMDI Copolymer, Ammonium Lauryl Sulfate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca (Tea Tree) Alternifolia Leaf Oil

WARNINGS

Warnings - For external use only

PRINCIPAL DISPLAY PANEL

Manufactured for Dermaquest®, Inc.

Hayward, CA - 94544

1272 GK,NL Made in USA

Dermaquest Inc.

INGREDIENTS AND APPEARANCE

DERMACLEAR BHA CLEANSER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
TEA TREE OIL (UNII: VIF565UC2G)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4065-2	1 in 1 CARTON	05/02/2014
1	NDC: 62742-4065-1	177.4 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 final	part333D	05/02/2014

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs Inc		926831603	manufacture(62742-4065)