CLEAR CELL CLARIFYING ACNE- benzoyl peroxide lotion

Clear Cell Clarifying Acne by

Drug Labeling and Warnings

Clear Cell Clarifying Acne by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzoyl Peroxide 5 %

PURPOSE

Purpose:

Acne Treatment

INDICATIONS & USAGE

Use:

For the treatment of acne

WARNINGS

Warning

For external use only

DO NOT USE

Do not use if you

have very sensitive skin

are sensitive to benzoyl peroxide

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

Stop use and ask a doctor if

Irritation becomes severe

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

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

Other information

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

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 lotion

Product 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)