Acne Treatment Lotion Benzoyl Peroxide Lotion Usp 5%

Acne Treatment Lotion Benzoyl Peroxide Lotion Usp 5%
SPL v14
SPL
SPL Set ID b4844539-bdd2-42a6-b946-6028de4f3cf1
Route
TOPICAL
Published
Effective Date 2013-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
C13-14 Isoparaffin Ethylhexylglycerin Lanolin Oil Laureth-4 Laureth-7 Magnesium Aluminum Silicate Phenoxyethanol Propylene Glycol Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-11-01

Description

Benzoyl Peroxide 5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5%

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

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.
Active Ingredient

Benzoyl Peroxide 5%

Do Not Use If You

  • have very sensitive skin.
  • are sensitive to Benzoyl Peroxide.
Other Information
  •  store at room temperature (59-86°F / 15-30°C)
Inactive Ingredients

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

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.
Keep Out of Reach of Children.

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

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.
Skintx Acne Treatment Lotion Benzoyl Peroxide Lotion Usp 5%


Structured Label Content

Use

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

Purpose

Acne Treatment

Warnings

For external use only

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.
Active Ingredient

Benzoyl Peroxide 5%

Do Not Use If You (Do not use if you)

  • have very sensitive skin.
  • are sensitive to Benzoyl Peroxide.
Other Information
  •  store at room temperature (59-86°F / 15-30°C)
Inactive Ingredients

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

When Using This Product (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 (Stop use and ask a doctor if)
  • irritation becomes severe.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Are (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.
Skintx Acne Treatment Lotion Benzoyl Peroxide Lotion Usp 5% (SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)