Label: CLEAR CELL CLARIFYING ACNE- benzoyl peroxide lotion
- NDC Code(s): 62742-4208-1, 62742-4208-2, 62742-4208-3
- Packager: Allure Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 21, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
-
WHEN USING
When using this product
Skin irritaion 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
Avoid unnecessary sun exposure and use a sunscreen
Aviod contact with the eyes, lips, and mouth
Avoid contact with hair and dyed fabrics,which may be bleached by this product
Skin irritation may occur,characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Direction
Clean the skin thoroughly before applying this product
Cover the entire affected area with a thin layer one to three time 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 SAFETY INFORMATION
-
INACTIVE INGREDIENT
Inactive ingredients
Water/Aqua/Eau,Aloe Barbadensis
Leaf Juice,Glycerin,Carbomer,
Sodium Citrate, Phenoxyethanol,
Tocopheryl Acetate, Kaolin,
Butylene Glycol, Sodium
Hydroxide, Caprylyl Glycol,
Melaleuca Alternifolia (Tea Tree)
Leaf Oil, Xanthan Gum, Arnica
Montana Flower Extract,
Ethylhexylglycerin,Hexylene
Glycol, Propanediol, PEG-8/SMDI
Copolymer,Eucalyptus Globulus
Leaf Oil, Diethylhexyl Sodium
Sulfosuccinate, Sodium Phytate,
Melia Azadirachta Leaf Extract,
Limonene, Cinnamimum Camphora
(Camphor) Bark Oil, Sodium
Benzoate, Camellia Sinensis Leaf
Extract, Oryza Savita (Rice) Bran
Extract, Boswellia Serrata
Extract, Honey Extract,
Dimethicone, Silica, Sorbitan
Stearate, PEG-40 Stearate,
Linalool, Aesculus Hippocastanum
(Horse Chestnut) Extract,
Anthemis Nobilis Flower Extract,
Oligopeptide-10, Crystalline
Silica, Potassium Sorbate.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLEAR CELL CLARIFYING ACNE
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4208 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) SODIUM CITRATE (UNII: 1Q73Q2JULR) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HONEY (UNII: Y9H1V576FH) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHYTATE SODIUM (UNII: 88496G1ERL) CAMPHOR OIL (UNII: 75IZZ8Y727) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) KAOLIN (UNII: 24H4NWX5CO) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TEA TREE OIL (UNII: VIF565UC2G) XANTHAN GUM (UNII: TTV12P4NEE) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPANEDIOL (UNII: 5965N8W85T) PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6) DOCUSATE SODIUM (UNII: F05Q2T2JA0) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) LIMONENE, (+)- (UNII: GFD7C86Q1W) SODIUM BENZOATE (UNII: OJ245FE5EU) RICE BRAN (UNII: R60QEP13IC) HORSE CHESTNUT (UNII: 3C18L6RJAZ) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) DIMETHICONE (UNII: 92RU3N3Y1O) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) SODIUM HYDROXIDE (UNII: 55X04QC32I) EUCALYPTUS OIL (UNII: 2R04ONI662) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-40 STEARATE (UNII: ECU18C66Q7) LINALOOL, (+/-)- (UNII: D81QY6I88E) OLIGOPEPTIDE-10 (UNII: Q46328TRNK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4208-1 7 g in 1 TUBE; Type 0: Not a Combination Product 03/21/2022 2 NDC:62742-4208-3 1 in 1 CARTON 03/21/2022 2 NDC:62742-4208-2 48 g 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 03/21/2022 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4208)
