Label: BREAKOUT CONTROL ACNE TREATMENT- benzoyl peroxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-124-01, 49825-124-02 - Packager: Bioelements, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 27, 2012
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ACTIVE INGREDIENT
Active ingredient Purpose
Benzoyl Peroxide 5% Acne treatment
Keep out of reach of children. If swallowed get medical help or contact a poison control center right away
Warnings
For external use only
When using this product
- Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time.
- Avoid unnecessary sun exposure and use a sunscreen
- Avoid contact with with the 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 concentration.
- Do not use if you:
Have very sensitive skin
Are sensitive to benzoyl peroxide
Directions
Cleanse the skin thoroughly before applying this product
cover the entire with a thin layer one to three times daily
Because excessive drying of the skin may occur, start with one application daily then gradually increase to two or three 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
If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BREAKOUT CONTROL ACNE TREATMENT
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PENTYLENE GLYCOL (UNII: 50C1307PZG) SQUALENE (UNII: 7QWM220FJH) POLYSORBATE 60 (UNII: CAL22UVI4M) ALOE VERA LEAF (UNII: ZY81Z83H0X) FYTIC ACID (UNII: 7IGF0S7R8I) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49825-124-02 1 in 1 BOX 1 NDC:49825-124-01 29 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 03/26/2012 Labeler - Bioelements, Inc. (174813923) Registrant - Bioelements, Inc. (174813923) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises Ltd 017701475 manufacture