LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR CLARIFYING- salicylic acid solution

La Roche Posay Laboratoire Dermatologique Effaclar Clarifying by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Effaclar Clarifying 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 0.5%

Purpose

Acne treatment

Use

for the treatment of acne

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

Other information

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Inactive ingredients

water, alcohol denat., propanediol, glycolic acid, sodium hydroxide, capryloyl glycine, phenoxyethanol, benzyl alcohol, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, menthol, tremella fuciformis polysaccharide, butylene glycol, ophiopogon japonicus root extract, scutellaria baicalensis root extract

Questions or comments?

1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR CLARIFYING 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
MENTHOL (UNII: L7T10EIP3A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-024-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2014
2	NDC: 49967-024-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/01/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-024)