Label: BREAKOUT CONTROL BIOELEMENTS- benzoyl peroxide cream
- NDC Code(s): 56152-4009-1, 56152-4009-2
- Packager: Cosmetic Enterprises Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredient Purpose
Benzoyl Peroxide 5% Acne treatment
Uses
For the treatment of acne
Helps prevent new acne blemishes
Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away
Stop use and ask a doctor if:
irritation becomes severe
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 BIOELEMENTS
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-4009 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 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PENTYLENE GLYCOL (UNII: 50C1307PZG) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) 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:56152-4009-2 1 in 1 CARTON 06/14/2013 1 NDC:56152-4009-1 29 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 06/14/2013 Labeler - Cosmetic Enterprises Ltd (017701475)
