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 KATE SOMERVILLE SKINCARE, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZOYL PEROXIDE- 5%

PURPOSE

ACNE TREATMENT

USE

• FOR THE TREATMENT OF ACNE
• HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

WHEN USING THIS PRODUCT

• USING OTHER TOPICAL  ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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 UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
• AVOID CONTACT WITH EYES, LIPS, AND MOUTH.
• AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.
• SKIN IRRITATION MY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLE SWELLING. IRRITATION MY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.

STOP USE

STOP USE AND ASK A DOCTOR IF SKIN 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

• CLEANSE SKIN THOROUGHLY BEFORE APPLYING. COVER THE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. 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. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCT 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.

OTHER INFORMATION

• YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PT

INACTIVE INGREDIENTS

WATER/AQUA/EAU, PPG-2 MYRISTYL ETHER PROPIONATE, ARGANIA SPINOSA KERNEL EXTRACT, PEG-40 STEARATE, 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, PALMITIC ACID, SODIUM ASCORBATE, SODIUM HYDROXIDE, EDTA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI BAC ACNE CLEARING 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43479-105
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
WATER (UNII: 059QF0KO0R)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
PEG-40 STEARATE (UNII: ECU18C66Q7)
SAW PALMETTO (UNII: J7WWH9M8QS)
SESAME SEED (UNII: 7Y1255HVXR)
ALCOHOL (UNII: 3K9958V90M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW) (UNII: XRK36F13ZZ)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE SODIUM (UNII: MP1J8420LU)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CERAMIDE 2 (UNII: C04977SRJ5)
CERAMIDE 3 (UNII: 4370DF050B)
OLEIC ACID (UNII: 2UMI9U37CP)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM ASCORBATE (UNII: S033EH8359)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETIC ACID (UNII: 9G34HU7RV0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43479-105-52	1 in 1 BOX	06/22/2014
1	NDC: 43479-105-12	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/22/2014

Labeler - KATE SOMERVILLE SKINCARE, LLC (615155533)