OTC Medication Information: O SKIN ACNE MODERATE

O SKIN ACNE MODERATE- benzoyl peroxide cream
O SKIN CARE LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 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 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, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, BENZYL ALCOHOL, CAPRYLHYDROXAMIC ACID, GLYCRIN

01b LBL_O Skin_Acne Cream Moderate
(click image for full-size original)

O SKIN ACNE MODERATE
benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71421-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
POLYACRYLAMIDE (10000 MW)
C13-14 ISOPARAFFIN
LAURETH-7
BENZYL ALCOHOL
CAPRYLHYDROXAMIC ACID
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71421-101-11 60 mL in 1 BOTTLE None
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)
Registrant — O SKIN CARE LLC (021275401)

Revised: 12/2022 O SKIN CARE LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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