O SKIN ACNE MODERATE- benzoyl peroxide cream

O SKIN ACNE by

Drug Labeling and Warnings

O SKIN ACNE by is a Otc medication manufactured, distributed, or labeled by O SKIN CARE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

BENZOYL PEROXIDE  5%

PURPOSE

ACNE TREATMENT

USE:

FOR THE TREATMENT OF ACNE

DIRECTIONS:

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT. PAT A THIN LAYER TO AFFECTED AREA DAILY MORNING AND NIGHT AND ALLOW TO DRY.

• BECAUSE EXCESSIVE DRYING MAY OCCUR, START WITH ONCE DAILY APPLICATION.
• IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.

WARNINGS:

FOR EXTERNAL USE ONLY.

DO NOT USE

DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE. THIS PRODUCT MAY CAUSE IRRITATION.

ASK A PHYSICIAN OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A PHYSICIAN. AVOID UNNECESSARY SUN EXPOSURE. USE A SUNSCREEN WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS.

STOP USE AND ASK A PHYSICIAN IF SKIN IRRITATION OCCURS, AND BECOMES SEVERE.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. KEEP AWAY FROM LIPS AND MOUTH. IF SWALLOWED, GET MEDICAL HELP OR CONTACT THE POISON CONTROL CENTER RIGHT AWAY.

OTHER INFORMATION.

THIS PRODUCT MAY BLEACH HAIR OR DYE FABRICS. AVOID STORING AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

INACTIVE INGREDIENTS:

DEIONIZED WATER, PROPYLENE GLYCOL, CARBOMER 940, SODIUM HYDROXIDE, CPE 722.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

O SKIN ACNE  MODERATE
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71421-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71421-101-11	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/01/2017

Labeler - O SKIN CARE LLC (021275401)

Establishment
Name	Address	ID/FEI	Business Operations
PRIVATE LABEL PARTNERS		046033481	manufacture(71421-101)