Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7a0f18cb-c79c-4f70-872c-c4958b793e59
Route
TOPICAL
Published
Effective Date 2011-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Glycerin Petrolatum Water Alkyl (c12-15) Benzoate Mineral Oil Sodium Cocoyl Isethionate Zinc Lactate Sodium C14-16 Olefin Sulfonate Potassium Metaphosphate Menthol Titanium Dioxide Carbomer 934 Trolamine Carbomer Interpolymer Type A (55000 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-10-25

Description

BENZOYL PEROXIDE 10%

Purpose

ACNE TREATMENT


Medication Information

Purpose

ACNE TREATMENT

Description

BENZOYL PEROXIDE 10%

Uses

FOR THE TREATMENT OF ACNE.

Warnings

FOR EXTERNAL USE ONLY.

Directions
  • WET FACE. GENTLY MASSAGE ALL OVER FACE FOR 20-30 SECONDS AVOIDING EYE AREA.  RINSE THOROUGHLY AND PAT DRY.

  • SINCE EXCESSIVE DRYNES OF SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY AND INCREASE TO TWO TIMES A DAY IF NEEDED OR DIRECTED BY A DOCTOR. 

  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. 

  • IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT.  IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USING BOTH PRODUCTS AND ASK A DOCTOR.

Active Ingredient

BENZOYL PEROXIDE 10%

Other Information

KEEP TIGHTLY CLOSED.  AVOID STORING AT TEMPERATURES ABOVE 90 DEGREES FAHRENHEIT.

Inactive Ingredients

GLYCERIN, PETROLATUM, WATER, SODIUM C12-15 ALKYL BENZOATE, MINERAL OIL, SODIUM COCOYL ISETHIONATE, ZINC LACTATE, SODIUM C14-16 OLEFIN SULFONATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, POTASSIUM POLYPHOSPHATE, MENTHOL, FRAGRANCE, TITANIUM DIOXIDE, CARBOMER, TRIETHANOLAMINE.

Front and Back Labels

Questions Or Comments

1-888-309-9030

When Using the Product
  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
  • AVOID CONTACT WITH EYES, LIPS AND MOUTH.
  • AVOID CONTACT WITH HAIR OR 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 CONCENTRATION.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.  AVOID CONTACT WITH EYES.  IF CONTACT OCCURS FLUSH THOROUGHLY WITH WATER.

Stop Using This Product and Ask Doctor If
IRRITATION OR REDNESS BECOMES SEVERE.


Structured Label Content

Uses (USES)

FOR THE TREATMENT OF ACNE.

Purpose (PURPOSE)

ACNE TREATMENT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)
  • WET FACE. GENTLY MASSAGE ALL OVER FACE FOR 20-30 SECONDS AVOIDING EYE AREA.  RINSE THOROUGHLY AND PAT DRY.

  • SINCE EXCESSIVE DRYNES OF SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY AND INCREASE TO TWO TIMES A DAY IF NEEDED OR DIRECTED BY A DOCTOR. 

  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. 

  • IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT.  IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USING BOTH PRODUCTS AND ASK A DOCTOR.

Active Ingredient (ACTIVE INGREDIENT)

BENZOYL PEROXIDE 10%

Other Information (OTHER INFORMATION)

KEEP TIGHTLY CLOSED.  AVOID STORING AT TEMPERATURES ABOVE 90 DEGREES FAHRENHEIT.

Inactive Ingredients (INACTIVE INGREDIENTS)

GLYCERIN, PETROLATUM, WATER, SODIUM C12-15 ALKYL BENZOATE, MINERAL OIL, SODIUM COCOYL ISETHIONATE, ZINC LACTATE, SODIUM C14-16 OLEFIN SULFONATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, POTASSIUM POLYPHOSPHATE, MENTHOL, FRAGRANCE, TITANIUM DIOXIDE, CARBOMER, TRIETHANOLAMINE.

Front and Back Labels (Front and back labels)

Questions Or Comments (QUESTIONS OR COMMENTS)

1-888-309-9030

When Using the Product (WHEN USING THE PRODUCT)
  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
  • AVOID CONTACT WITH EYES, LIPS AND MOUTH.
  • AVOID CONTACT WITH HAIR OR 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 CONCENTRATION.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.  AVOID CONTACT WITH EYES.  IF CONTACT OCCURS FLUSH THOROUGHLY WITH WATER.

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)
IRRITATION OR REDNESS BECOMES SEVERE.


Advanced Ingredient Data


Raw Label Data

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