Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 70222480-0ede-4516-a8cd-d6d61e0ca3de
Route
TOPICAL
Published
Effective Date 2012-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Propylene Glycol Glyceryl Monostearate Bentonite Laureth-7 Carbomer 934 Potassium Hydroxide Aluminum Hydroxide Polyethylene Glycol 600 Isopropyl Myristate Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-06-06

Description

BENZOYL PEROXIDE 10%

Purpose

ACNE MEDICATION


Medication Information

Purpose

ACNE MEDICATION

Description

BENZOYL PEROXIDE 10%

Uses

FOR THE TREATMENT AND PREVENTION OF ACNE PIMPLES.

Warnings

FOR EXTERNAL USE ONLY. SUNSCREEN ALERT: AVOID UNNECESSARY SUNSCREEN EXPOSURE BY USING A SUNSCREEN.

Directions

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. START WITH 1 APPLICATION DAILY AND GRADUALLY INCREASE TO 2 TO 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. WHEN GOING OUTSIDE, USE A SUNSCREEN. ALLOW CREAM TO DRY AND FOLLOW DIRECTIONS IN THE SUNSCREEN LABELING. IF IRRITATION DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR.

Label Copy

Do Not Use If

YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO BENZOYL PEROXIDE OR IF YOU ARE TAKING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Active Ingredient

BENZOYL PEROXIDE 10%

Other Information

KEEP CAP TIGHTLY CLOSED. STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F).

Inactive Ingredients:

WATER (AQUA), C12-15 ALKYL BENZOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE, BENTONITE, LAURETH-7, CARBOMER, ALUMINUM HYDROXIDE, PEG-12, ISOPROPYL MYRISTATE, METHYLPARABEN, PROPYLPARABEN.

Questions Or Comments?

1-888-723-3929

When Using This Product

AVOID CONTACT WITH EYES, LIPS AND MOUTH. AVOID CONTACT WITH HAIR OR DYED FABRICS, INCLUDING CARPET AND CLOTHING WHICH MAY BE BLEACHED BY THIS PRODUCT. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask A Doctor If

SKIN IRRITATION, REDNESS, BURNING, ITCHING, PEELING OR SWELLING OCCURS AND LASTS. MILD IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.


Structured Label Content

Uses (USES)

FOR THE TREATMENT AND PREVENTION OF ACNE PIMPLES.

Purpose (PURPOSE)

ACNE MEDICATION

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. SUNSCREEN ALERT: AVOID UNNECESSARY SUNSCREEN EXPOSURE BY USING A SUNSCREEN.

Directions (DIRECTIONS)

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. START WITH 1 APPLICATION DAILY AND GRADUALLY INCREASE TO 2 TO 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. WHEN GOING OUTSIDE, USE A SUNSCREEN. ALLOW CREAM TO DRY AND FOLLOW DIRECTIONS IN THE SUNSCREEN LABELING. IF IRRITATION DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR.

Label Copy (LABEL COPY)

Do Not Use If (DO NOT USE IF)

YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO BENZOYL PEROXIDE OR IF YOU ARE TAKING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Active Ingredient (ACTIVE INGREDIENT)

BENZOYL PEROXIDE 10%

Other Information (OTHER INFORMATION)

KEEP CAP TIGHTLY CLOSED. STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F).

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), C12-15 ALKYL BENZOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE, BENTONITE, LAURETH-7, CARBOMER, ALUMINUM HYDROXIDE, PEG-12, ISOPROPYL MYRISTATE, METHYLPARABEN, PROPYLPARABEN.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-888-723-3929

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES, LIPS AND MOUTH. AVOID CONTACT WITH HAIR OR DYED FABRICS, INCLUDING CARPET AND CLOTHING WHICH MAY BE BLEACHED BY THIS PRODUCT. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

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.

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

SKIN IRRITATION, REDNESS, BURNING, ITCHING, PEELING OR SWELLING OCCURS AND LASTS. MILD IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.


Advanced Ingredient Data


Raw Label Data

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