NDC Code(s) : 69481-333-01
Packager : Pacific Bioscience Laboratories, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clarisonic Pore and Blemish Cleanser Acne TreatmentSalicylic Acid GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69481-333
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID20 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)
PEG-150 PENTAERYTHRITYL TETRASTEARATE(UNII: 8L4OOQ76AM)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES(UNII: GO50W2HWO8)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM BENZOATE(UNII: OJ245FE5EU)
EDETATE SODIUM(UNII: MP1J8420LU)
CAPRYLOYL SALICYLIC ACID(UNII: 5F7PJF6AA4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
MENTHOL(UNII: L7T10EIP3A)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
POLYQUATERNIUM-47 (METHACRYLAMIDOPROPYLTRIMETHYLAMMONIUM CHLORIDE-CO-METHYL ACRYLATE-CO-ACRYLIC ACID 45:10:45; 1200000 MW)(UNII: F11YNO8FDQ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69481-333-01120 mL in 1 TUBE Type 0: Not a Combination Product08/10/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 08/10/2017 06/10/2024

LABELER - Pacific Bioscience Laboratories, Inc.(024874849)

Establishment
Name Address ID/FEI Business Operations
L'Oreal USA, Inc. 185931458 manufacture(69481-333), pack(69481-333)

PRINCIPAL DISPLAY PANEL

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