SkinTx Acne Treatment description, usages, side effects, indications, overdosage, supplying and lots more!

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SkinTx Acne Treatment

Vivier Pharma, Inc.

SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

SkinTx Acne Treatment

SkinTx Acne Treatment

BENZOYL PEROXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67226-2050
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 50 mg

Inactive Ingredients

Ingredient Name Strength
C13-14 ISOPARAFFIN
ETHYLHEXYLGLYCERIN
LANOLIN OIL
laureth-4
LAURETH-7
magnesium aluminum silicate
PHENOXYETHANOL
propylene glycol
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 TUBE
2 NDC:67226-2050-3 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-11-01


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Be sure to consult your doctor before taking any medication!
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