KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL ACNE TREATMENT FACIAL- salicylic acid lotion

Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment Facial by

Drug Labeling and Warnings

Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment Facial by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 1.5%

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

• clean the skin thoroughly before applying this product
• 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

Inactive ingredients

water, aloe barbadensis leaf juice, di-C12-13 alkyl malate, niacinamide, cyclohexasiloxane, propylene glycol, aluminum starch octenylsuccinate, PEG-100 stearate, glyceryl stearate, cetyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, capryloyl salicylic acid, xanthan gum, zinc PCA, zingiber officinale (ginger) root extract, stearyl alcohol, myristyl alcohol, citric acid, potassium sorbate, octadecenedioic acid, sodium benzoate, citral, BHT

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL ACNE TREATMENT FACIAL 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-875
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-875-01	1 in 1 CARTON	11/01/2016
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-875-02	5 mL in 1 PACKET; Type 0: Not a Combination Product	11/01/2016
3	NDC: 49967-875-03	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	11/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-875)