LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER- salicylic acid gel 
L'Oreal USA Products Inc

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Drug Facts

Active ingredient

Salicylic acid 2%

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

Inactive ingredients

water, sodium laureth sulfate, decyl glucoside, glycerin, sodium chloride, coco-betaine, sodium hydroxide, PEG-150 pentaerythrityl tetrastearate, citric acid, hexylene glycol, PEG-6 caprylic/capric glycerides, zinc gluconate, tetrasodium EDTA, polyquaternium-47, menthol, capryloyl salicylic acid, sodium benzoate

Questions or comments?

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LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCO-BETAINE (UNII: 03DH2IZ3FY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
EDETATE SODIUM (UNII: MP1J8420LU)  
POLYQUATERNIUM-47 (METHACRYLAMIDOPROPYLTRIMETHYLAMMONIUM CHLORIDE-CO-METHYL ACRYLATE-CO-ACRYLIC ACID 46:8:46; 1300000 MW) (UNII: G938900MID)  
MENTHOL (UNII: L7T10EIP3A)  
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-402-01200 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2022
2NDC:49967-402-02100 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2022
3NDC:49967-402-0315 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00608/01/2022
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-402) , pack(49967-402)

Revised: 1/2024
Document Id: e8bc575a-3c48-4b77-976d-e8ba006dccd8
Set id: 4795cc87-c663-4702-b65d-ce85203f1258
Version: 9
Effective Time: 20240102
 
L'Oreal USA Products Inc