SkinTx Acne Treatment

Dosage form: lotion
Ingredients: BENZOYL PEROXIDE 50mg in 1mL
Labeler: Vivier Pharma, Inc.
NDC Code: 67226-2050

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.

SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%

SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Use

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

Warnings

For external use only

Ask a doctor before use if you are
  • using other topical acne medications at the same time or immediately following 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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if you

  • have very sensitive skin.
  • are sensitive to Benzoyl Peroxide.

When using this product
  • 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 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 oncentration.

Stop use and ask a doctor if
  • irritation becomes severe.

Directions
  • Wash hands with a non-medicated soap (contains no Benzoyl Peroxide).
  • Cleanse and dry face thoroughly 5 minutes before use.
  • Using fingertips apply evenly to affected areas.
  • Use both morning and night or as directed by a physician.
  • If dryness or peeling occurs, reduce application to once a day or every other day.
  • Fair- skinned individuals should begin with one application.
  • For more severe cases, and/or if substantial improvement is not apparent within 3 to 4 weeks, consult a health care practitioner.

Inactive Ingredients

C13-14 Isoparaffin, Ethylhexylglycerin, Lanolin Oil, Laureth-4, Laureth-7, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Water/Eau, Xanthan Gum.

Other Information
  •  store at room temperature (59-86°F / 15-30°C)

SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%

SKINTX ACNE TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
C13-14 ISOPARAFFIN 
ETHYLHEXYLGLYCERIN 
LANOLIN OIL 
LAURETH-4 
LAURETH-7 
MAGNESIUM ALUMINUM SILICATE 
PHENOXYETHANOL 
PROPYLENE GLYCOL 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:67226-2050-31 TUBE (TUBE) in 1 BOX
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/01/2011
Labeler - Vivier Pharma, Inc. (250996550)

Revised: 10/2014
 
Vivier Pharma, Inc.

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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