AMBI SKINCARE EVEN AND CLEAR EXFOLIATING WASH TREATMENT- salicylic acid cream
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Salicylic acid 0.5%

Purpose

Acne medication

Uses

For the treatment of acne

Warnings

For external use only

When using this product with other topical acne medications at the same time or immediately following use of the product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

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

Directions

•: moisten face and squeeze cleanser into your hand.
•: massage gently in circular motion over face
•: rinse thoroughly.
•: if you experience dryness or irritation, use less frequently.

Inactive ingredients

butylene glycol, cetyl alcohol, citric acid, fragrance, glycine soja (soybean) protein, menthyl lactate, PEG-16 soy sterol, polyethylene, polysorbate 60, potassium cetyl phosphate, PPG-15 stearyl ether, sodium ascorbyl phosphate, steareth-21, tocopheryl acetate, water, xanthan gum

Questions or comments?

1-800-946-6354

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AMBI SKINCARE EVEN AND CLEAR EXFOLIATING WASH TREATMENT
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49967-059
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
STEARETH-21 (UNII: 53J3F32P58)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49967-059-01	141 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2017	08/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/10/2017	08/24/2020

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg, LLC		927768135	MANUFACTURE(49967-059)

Revised: 12/2019

Document Id: 3fb80f61-dcff-4c8f-9b26-7fb5df124408

Set id: 8f4a467b-375a-484f-9a49-b7544381e20b

Version: 2

Effective Time: 20191231

L'Oreal USA Products Inc