SOFIE PAVITT FACE RESET BENZOYL PEROXIDE ACNE TREATMENT MASK- benzoyl peroxide paste

Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask by

Drug Labeling and Warnings

Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient/Purpose

Benzoyl Peroxide............Acne Treatment

Use

For the treatment of acne

Warnings

For external use only

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

Ask doctor before use

if you have redness over the affected area

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.
• Avoid unnecessary sun exposure and use a sunscreen
• Avoid 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.

Directions

• Clean the skin throughly before applying this product
• Apply to hands, add and massage gently onto the face. Allow to dry. Rinse thoroughly.
• Use once a day or as directed by a doctor.
• If dryness or peeling occurs, reduce application to once every other day.
• If going outside, apply sunscreen after using this product.
• If irritation or sensitivity develops, discontinue use and consult a doctor.

Other Information

Store at room temperature 20°-25°C (68°-77°F)

Protect from heat and direct sunlight.

Inactive Ingredients

Water, Kaolin, Bentonite, Propanediol, Sodium Hyaluronate, Glycolic Acid, Niacinamide, Panthenol, Phenoxyethanol, Ethylhexylglycerin,  Hydroxyethylcellulose, Carbomer, Xanthan Gum, Tocopheryl Acetate, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFIE PAVITT FACE RESET BENZOYL PEROXIDE ACNE TREATMENT MASK 
benzoyl peroxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-7301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	Benzoyl Peroxide	0.05 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
BENTONITE (UNII: A3N5ZCN45C)
PROPANEDIOL (UNII: 5965N8W85T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCOLIC ACID (UNII: 0WT12SX38S)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-7301-1	1 in 1 CARTON	11/11/2024
1		0.0618 kg 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 Drug	M006	11/11/2024

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-7301) , label(52261-7301) , pack(52261-7301)