ANTI BAC ACNE CLEARING- benzoyl peroxide lotion

Anti Bac Acne Clearing by

Drug Labeling and Warnings

Anti Bac Acne Clearing by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprise Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

PURPOSE

Use

• For the treatment of acne
• Helps keep skin clear of new acne blemishes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if irritation becomes severe.

WARNINGS

Warnings

For external use only

• When using this product
• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
• Do not use this product if you have very sensitive skin or if you are sensitive to Benzoyl Peroxide.
• Avoid unnecesary 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 possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

DOSAGE & ADMINISTRATION

Directions

• Clease Skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 days. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor 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 products and ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Water/Aqua/Eau, PPG-2 Myristyl Ether Propionate, Argania Spinosa Kernel Extract, PEG-40 Sterate, Serenoa Serrulata Fruit Extract, Sesamum Indicum (sesame) Seed Extract, Alcohol Denat., Sorbitan Stearate, Hydrogenated Methyl Abeitate, Methyl Methacrylate Crosspolymer, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Tetrasodium EDTA, Hydrogenated Lecithin, Cholesterol, Ceramide NS, Ceramide NP, Oleic Acid, Plamitic Acid, Sodium Ascorbate, Sodium Hydroxide, EDTA, Ethylhexylglycerin, Phenoxyethanol

PRINCIPAL DISPLAY PANEL

Kate Somerville

Acne/Peau acneique

5% Benzoyl Peroxide

Anti Bac

Acne Clearing Lotion

Lotion purifiante actibacterienne

50mL 1.7 Fl Oz Liq

INGREDIENTS AND APPEARANCE

ANTI BAC ACNE CLEARING 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-4012
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-40 STEARATE (UNII: ECU18C66Q7)
WATER (UNII: 059QF0KO0R)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
SERENOA REPENS WHOLE (UNII: 487DXM62F2)
SESAME SEED (UNII: 7Y1255HVXR)
SODIUM ASCORBATE (UNII: S033EH8359)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETIC ACID (UNII: 9G34HU7RV0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CERAMIDE NS DILAURATE (UNII: 1SL625KAAV)
CERAMIDE NP (UNII: 4370DF050B)
OLEIC ACID (UNII: 2UMI9U37CP)
PALMITIC ACID (UNII: 2V16EO95H1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-4012-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/14/2019

Labeler - Cosmetic Enterprise Ltd (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprise Ltd		017701475	manufacture(56152-4012)