FDA Label for Benzoyl Peroxide 10% Topical Wash
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- INSTRUCTIONS FOR USE
- KEEP OUT OF THE REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 5% 5 OZ BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 5% 8 OZ BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 10% 5 OZ BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 10% 8 OZ BOTTLE LABEL
Benzoyl Peroxide 10% Topical Wash Product Label
The following document was submitted to the FDA by the labeler of this product Medcore Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient
BENZOYL PEROXIDE 5% or 10%
Purpose
Acne medication
Uses
For the treatment of acne
Warnings
For external use ONLY. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. Avoid unnessary sun exposure and use a sunscreen. Avoid contact with eyes, lips and mouth. Avoid contact with hair,dyed fabrics, which may be bleached by thisproduct. 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 lower concentration.If irritation or sensitivy develops stop use of both products and ask a doctor.
Instructions For Use
Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, 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
Keep Out Of The Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
| adults and children 2 years and older | apply externally to the affected area up to 3 to 4 times a day |
| children under 2 years | ask a doctor |
Other Information
Store at room temperature 15°-30°C(59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerinGLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol sodium lauroamphoacetate sodium coco-sulfate xanthan gum Water PHENOXYETHANOL
Principal Display Panel - 5% 5 Oz Bottle Label
NDC: 82461-312-05
Medcore LLC
BENZOYL PEROXIDE 5% Acne wash
5 OZ
Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269
Principal Display Panel - 5% 8 Oz Bottle Label
NDC: 82461-312-08
Medcore LLC
BENZOYL PEROXIDE 5% Acne wash
8 OZ
Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269
Principal Display Panel - 10% 5 Oz Bottle Label
NDC: 82461-313-05
Medcore LLC
BENZOYL PEROXIDE 10% Acne wash
5 OZ
Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269
Principal Display Panel - 10% 8 Oz Bottle Label
NDC: 82461-313-08
Medcore LLC
BENZOYL PEROXIDE 10% Acne wash
8 OZ
Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269
* Please review the disclaimer below.
