Label: BENZOYL PEROXIDE gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-019-02 - Packager: GERITREX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 10, 2016
If you are a consumer or patient please visit this version.
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- Drug Facts
- Use
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Directions
Shake well, wet face, apply to hands, add water, work into a lather, and massage gently onto face. Rinse thoroughly and pat dry
use 2 to 3 times daily or as directed by a doctor if bothersome dryness of peeling occurs, reduce application to once a day or every other
day if going outside use sunscreen. After washing and drying face follow directions in the sunscreen labeling if irritation or sensitivity develops,
discontinue use of both products and consult a doctor
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Warnings
For external use only
Do not use if you have very sensitive skin of if you are sensitive to benzoyl peroxide
When using this product avoid unnecessary sun exposure and use a sunscreen using other topical acne drugs at the same time or right
after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a
doctor. Irritation may develop, such as redness, burning, itching, peeling, or possibly swelling more frequent use or higher concentraions may
aggravate such irritation: mild irritation may be reduced by using the product less frequently or in lower concnetraion. Keep away from eyes,
lips, mouth It may bleach hair of dye fabrics
Stop use and ask a doctor if irritaion becomes severe and continue.
- Inactive Ingrdients
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER 940 (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) DMDM HYDANTOIN (UNII: BYR0546TOW) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) MINERAL OIL (UNII: T5L8T28FGP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PEG-200 DILAURATE (UNII: TWV5J70L88) GLYCERIN (UNII: PDC6A3C0OX) SILICON (UNII: Z4152N8IUI) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) DIETHYLENE GLYCOL DISTEARATE (UNII: 617Q4OD69O) DISODIUM HEDTA (UNII: KME849MC7A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-019-02 56 g in 1 TUBE; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/31/2015 Labeler - GERITREX LLC (112796248) Registrant - GERITREX LLC (112796248) Establishment Name Address ID/FEI Business Operations GERITREX LLC 112796248 manufacture(54162-019)