CLEAR CELL CLARIFYING ACNE- benzoyl peroxide lotion 
Allure Labs

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

Benzoyl Peroxide 5 %

Purpose:

Acne Treatment

Use:

For the treatment of acne

Warning

For external use only

Do not use if you

have very sensitive skin

are sensitive to benzoyl peroxide

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 and ask a doctor if

Irritation becomes severe

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away

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 information

Avoid storing at extreme temperatures (below 40°F and above 100°F)

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.

Clear cell clarifying acne lotion

CLEAR CELL CLARIFYING ACNE 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4208-17 g in 1 TUBE; Type 0: Not a Combination Product03/21/2022
2NDC:62742-4208-31 in 1 CARTON03/21/2022
2NDC:62742-4208-248 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/21/2022
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4208)

Revised: 3/2022
Document Id: da87cbbf-12cb-3224-e053-2995a90a25e4
Set id: da87cbbf-12ca-3224-e053-2995a90a25e4
Version: 1
Effective Time: 20220321
 
Allure Labs