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O SKIN ACNE MODERATE

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 5g in 100mL
Labeler: O SKIN CARE LLC
NDC Code: 71421-101

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.

O SKIN - ACNE CREAM MODERATE

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, CARBOMER 940, SODIUM HYDROXIDE, CPE 722.

O SKIN ACNE  MODERATE
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71421-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
CARBOMER 940 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:71421-101-1160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/01/2017
Labeler - O SKIN CARE LLC (021275401)
Establishment
NameAddressID/FEIOperations
PRIVATE LABEL PARTNERS046033481manufacture(71421-101)

Revised: 09/2017
 
O SKIN CARE LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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