SPL v3
SPL
SPL Set ID fb6ee4a6-178a-461f-84b2-ca3377686888
Route
TOPICAL
Published
Effective Date 2013-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Water Diglycerin Propanediol Butylene Glycol Salicylic Acid Allantoin .alpha.-bisabolol, (+/-)- Glycerin Angelica Sinensis Whole Avena Sativa Top Lecithin, Soybean Ethylhexylglycerin Carbomer 934 Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aminomethylpropanol Phenoxyethanol Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-21

Description

ACTIVE INGREDIENT BENZOYL PEROXIDE 5%


Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

USES

  • TREATS ACNE
  • DRIES UP ACNE PIMPLES
  • HELPS PREVENT NEW ACNE PIMPLES
Dosage and Administration

DIRECTIONS

  • ON CLEAN AND DRY SKIN, APPLY A SMALL AMOUNT EVENLY OVER THE AFFECTED AREAS.
  • AVOID THE DELICATE EYE AREA.
  • START WITH ONE APPLICATION DAILY THEN GRADUALLY INCREASE TO TWO TIMES DAILY IF NEEDED, OR AS DIRECTED BY A DOCTOR.
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
  • CONSULT A PHYSICIAN BEFORE USE.
Description

ACTIVE INGREDIENT BENZOYL PEROXIDE 5%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

Section 50567-7

WHEN USING THIS PRODUCT

  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
  • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH. AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THE 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.
  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME.
  • IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.
Section 50570-1

DO NOT USE

  • IF YOU HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE
Section 51727-6

INGREDIENTS

aqua (water), diglycerin, propanediol, butylene glycol, salicylic acid, allantoin, bisabolol, glycerin, angelica sinensis extract, avena sativa (oat) kernel extract, lecithin, ethylhexylglycerin, carbomer, acrylates/C10-30 alkyl acrylate , crosspolymer, aminomethyl propanol, phenoxyethanol, potassium sorbate

Section 51945-4

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

Section 60561-8

Other Information

Store at 15-30°C (59-86°F)


Structured Label Content

Indications and Usage (34067-9)

USES

  • TREATS ACNE
  • DRIES UP ACNE PIMPLES
  • HELPS PREVENT NEW ACNE PIMPLES
Dosage and Administration (34068-7)

DIRECTIONS

  • ON CLEAN AND DRY SKIN, APPLY A SMALL AMOUNT EVENLY OVER THE AFFECTED AREAS.
  • AVOID THE DELICATE EYE AREA.
  • START WITH ONE APPLICATION DAILY THEN GRADUALLY INCREASE TO TWO TIMES DAILY IF NEEDED, OR AS DIRECTED BY A DOCTOR.
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
  • CONSULT A PHYSICIAN BEFORE USE.
Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT

  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
  • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH. AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THE 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.
  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME.
  • IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.
Section 50570-1 (50570-1)

DO NOT USE

  • IF YOU HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE
Section 51727-6 (51727-6)

INGREDIENTS

aqua (water), diglycerin, propanediol, butylene glycol, salicylic acid, allantoin, bisabolol, glycerin, angelica sinensis extract, avena sativa (oat) kernel extract, lecithin, ethylhexylglycerin, carbomer, acrylates/C10-30 alkyl acrylate , crosspolymer, aminomethyl propanol, phenoxyethanol, potassium sorbate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

Section 60561-8 (60561-8)

Other Information

Store at 15-30°C (59-86°F)


Advanced Ingredient Data


Raw Label Data

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