ACNE TREATMENT CREAM cream

Acne Treatment Cream by

Drug Labeling and Warnings

Acne Treatment Cream by is a Otc medication manufactured, distributed, or labeled by Shenzhen Hengkaifeng Commerce and Trade Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzoyl peroxide 10%

Purpose

Acne Treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use

Do not use this if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

When using this product

keep away from eyes, lips and mouth

wavoid unnecessary sun exposure and use a sunscreen
avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly
swelling. Mild irritation may be reduced by using the product less frequenty or in a lower concentration.
Ifirritation becomes severe,discontinue use; ifirritation still continues, consulta doctor
wusing other topical acne medication at the same time or immediately following the use of this product may
increase dryness or iritation of the skin, lf this occurs, only one medication should be used unless directed
by a doctor.

Keep Out Of Reach Of Children

Keep out of reach of children.tfswallowed, get help or contact
a Poison Control Center right away.Avoid contact with the eyes. lf contact occurs,flush thoroughly with water.

Directions Of Safe Use:

Cleanse skin thoroughly before appying Acne Cream. Cover the enire afected
area with a thin layer 1-3 times daiy. lf bothersome dryness or peeing occurs, reduce application to once a day.

Other information

Keep tightly closed.Avoid storing at extreme temperatures (below 40° fand above 100° F).

Inactive ingredients

water,carbomer,disodium EDTA, hydroxypropyl methylcellulose, laureth-4,sodium hydroxide,hyaluronic acid,
niacinamide

DOSAGE & ADMINISTRATION

● adults and children 12 years of age and older:
● apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
● brush teeth thoroughly for at least 1 minute twice a day (morning and evening),
and not more than 3 times a day, or as recommended by a dentist or doctor.
Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out
after brushing.
● children under 12 years of age: Consult a dentist or doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE TREATMENT CREAM 
acne treatment cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84117-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYALURONIC ACID (UNII: S270N0TRQY)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84117-012-01	50 g in 1 CANISTER; Type 0: Not a Combination Product	07/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/03/2024

Labeler - Shenzhen Hengkaifeng Commerce and Trade Co., Ltd (444722774)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd		444722774	manufacture(84117-012) , label(84117-012)