Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR K ACNE TREATMENT- salicylic acid lotion 
Laboratoires Industriels de Vichy (LIDV)

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 1.5%

Warnings

For external use only

When using this product

using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor.

Stop use and ask a doctor if

irritation occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• cleanse the skin thoroughly before applying medication
• cover the entire affected area with a thin layer one to three times daily
• because too much 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 of peeling occurs, reduce application to once a day or every other day

Inactive ingredients

water, isononyl isononanoate, propylene glycol, dimethicone, aluminum starch octenylsuccinate, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, octyldodecanol, zinc PCA, sodium hydroxide, retinyl linoleate, capryloyl salicylic acid, xanthan gum, cetyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, fragrance

Uses

• for the treatment of acne
• clears blackheads and allows skin to heal

Purpose

Acne medication

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR K ACNE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66382-223
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)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
OCTYLDODECANOL (UNII: 461N1O614Y)
ZINC PIDOLATE (UNII: C32PQ86DH4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
RETINYL LINOLEATE (UNII: 61911N8D6W)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66382-223-01	1 in 1 CARTON	07/01/2011	06/01/2015
1		30 mL in 1 TUBE; 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	07/01/2011	06/01/2015

Labeler - Laboratoires Industriels de Vichy (LIDV) (282658798)

Revised: 8/2019

Document Id: 5f78f60b-13d7-4a9f-9b76-8160ab20a589

34390-5

Set id: 8b909b62-9879-4b12-9edb-2cea48c3c56d

Version: 4

Effective Time: 20190827