SPOT ACNE TREATMENT 0.75OZ- benzoyl peroxide gel

SPOT ACNE TREATMENT 0.75OZ by

Drug Labeling and Warnings

SPOT ACNE TREATMENT 0.75OZ by is a Otc medication manufactured, distributed, or labeled by Rejoice International Corp., China Ningbo Shangge Cosmetics Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Medication

Use

For the treatment of acne

Warnings

For external use only

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.

Do not use if you

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product

• avoid unnecessary sun exposure and use 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, charactherized 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 severs.

Keep out of reah of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times 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 directed by a doctor.
• if some dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

Store at 20ºC-25ºC (68ºF-77ºF)

Inactive ingredients

Water

Laureth-4

Carbomer

Ethylhexylglycerin

Hydroxypropyl Methylcellulose

Chlorphenesin

Sodium Hydroxide

Disodium EDTA

label

INGREDIENTS AND APPEARANCE

SPOT ACNE TREATMENT 0.75OZ 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)
LAURETH-4 (UNII: 6HQ855798J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-149-01	1 in 1 BOX	10/04/2023
1		21 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 Drug	M006	10/04/2023

Labeler - Rejoice International Corp. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetics Technology Corp.		529287434	manufacture(57337-149)