BENZOIL 12HR ACNE TREATMENT- benzoyl peroxide lotion

BENZOIL 12HR ACNE TREATMENT by

Drug Labeling and Warnings

BENZOIL 12HR ACNE TREATMENT by is a Otc medication manufactured, distributed, or labeled by THE SKINCARE COMPANY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZOYL PEROXIDE 3%

PURPOSE

ACNE TREATMENT

USE

FOR THE TREATMENT OF ACNE.

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

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.
• AVOID UNNECESSARY 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 POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.

STOP USE

STOP USE AND ASK A DOCTOR IF

• IRRITATION BECOMES SEVERE.

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.

DIRECTIONS

• 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 BELOW.
• 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 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

• ORGANIC INGREDIENTS ARE DENOTED WITH THE * SYMBOL
• STORE AT 4-25°c (39-77°f), OUT OF DIRECT SUNLIGHT

INACTIVE INGREDIENTS

ALCOHOL*, DIMETHYL ISOSORBIDE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL*, RICINUS COMMUNIS (CASTOR) SEED OIL*, WATER, XANTHAN GUM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZOIL 12HR ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71792-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CASTOR OIL (UNII: D5340Y2I9G)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71792-101-11	60 mL in 1 TUBE; Type 0: Not a Combination Product	10/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/12/2017

Labeler - THE SKINCARE COMPANY, INC. (314521346)

Establishment
Name	Address	ID/FEI	Business Operations
Fastfill Pack, Inc.		079348840	manufacture(71792-101)