ACNE SPOT TREATMENT- benzoyl peroxide cream

Acne Spot Treatment by

Drug Labeling and Warnings

Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by MONAT GLOBAL CORP, Dermacare MFG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzoyl Peroxide 5.00%

PURPOSE

Purpose

Acne Treatment

INDICATIONS & USAGE

Uses

• For the treatment of acne

WARNINGS

For external use only

Do not use if

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product

• skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.
• avoid unnecessary sun exposure and use sunscreen
• avoid contact with 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 consult

Stop use and consult with a doctor if

• irritation becomes severe.

Keep out of reach of children

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Directions

Directions

• Clean 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 as directed by a doctor.
• if bothersome 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 sak a doctor.

Sensitivity Test for a new User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Isostearyl Alcohol, Glycerin, Pentylene Glycol, Silica, Hamamelis Virginiana (Witch Hazel) Water, Epilobium Angustifolium Flower/Leaf/Stem Extract, Phragmites Communis Extract, Poria Cocos Extract, Niacinamide, Tocopheryl Acetate, Carbomer, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA.

Questions or Comments

Questions or comments?

Toll-free number 1-800-878-1978

PRIMARY PACKAGE

OUTER PACKAGE

INGREDIENTS AND APPEARANCE

ACNE SPOT TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78518-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
FU LING (UNII: XH37TWY5O4)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78518-013-01	1 in 1 CARTON	04/04/2023
1		15 mg 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	M006	04/04/2023

Labeler - MONAT GLOBAL CORP (027036949)

Establishment
Name	Address	ID/FEI	Business Operations
Dermacare MFG		116817470	manufacture(78518-013)