LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER- salicylic acid gel

La Roche Posay Effaclar Medicated Cleanser by

Drug Labeling and Warnings

La Roche Posay Effaclar Medicated Cleanser 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 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

• use twice daily
• wet face, then work product into a lather
• massage onto face, avoiding the eyes
• rinse well

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

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-402-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2022
2	NDC: 49967-402-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2022
3	NDC: 49967-402-03	15 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2022
4	NDC: 49967-402-04	50 mL in 1 TUBE; Type 0: Not a Combination Product	02/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/01/2022

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-402) , pack(49967-402)