CARING MILL ACNE TREATMENT- benzoyl peroxide cream

Caring mill Acne Treatment by

Drug Labeling and Warnings

Caring mill Acne Treatment by is a Otc medication manufactured, distributed, or labeled by FSA Store Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne medication

Use

For the management 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 timr. If irritation occurs, only use one topical acne medication at a time
• Avoid unnecessary sun exposure and use sunscreen
• Avoid contact with the eyes, lips, and mouth. If contact occurs, flush thorughly with water.
• Avoid contact with hair and dyed products, 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.

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide.

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 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 applicaiton to once a day or every other day 
• If going outside, apply sunscreen after using this product. If irritaion or sensitivity develops, stop use of both products and ask a doctor.

Other information

Protect from excessive heat (104°F/40°C).

Inactive ingredients

Water, Polyacrylate Crosspolymer-11, Laureth-4, Hydroxypropyl Methylcellulose, Silica, Methicone, Sodium Hydroxide, Disodium EDTA.

Package Labeling:

INGREDIENTS AND APPEARANCE

CARING MILL ACNE TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81522-951
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX)
LAURETH-4 (UNII: 6HQ855798J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHICONE (20 CST) (UNII: 6777U11MKT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81522-951-01	28 g in 1 TUBE; Type 0: Not a Combination Product	01/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	01/20/2024

Labeler - FSA Store Inc. (049283340)