FDA Label for Benzoyl Peroxide Cleanser
View Indications, Usage & Precautions
Benzoyl Peroxide Cleanser Product Label
The following document was submitted to the FDA by the labeler of this product Pharmco Laboratories Inc.. 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.
Other
Drug Facts
- Keep away from excessive heat or heat sources
Manufactured by:
Pharmco Laboratories Inc. • Titusville, FL 32780
Active Ingredient
Benzoyl Peroxide 3.5%
Purpose
Acne Treatment
Uses
- For the treatment of acne.
Warnings
- For external use only
Do Not Use If You
- Have very sensitive skin
- Are sensitive to benzoyl peroxide
When Using This Product
- Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- Avoid unnecessary sun exposure and use a sunscreen
- Avoid contact 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.
- If going outside, apply sunscreen after using this product.
Otc - Stop Use
- If sensitivity develops or irritation becomes severe, stop use and ask a doctor.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children
- If swallowed get medical help or call a poison control center immediately
Directions
- Use once or twice daily. Morning and/or night.
- Apply to damp skin and Wash-In for up to 1 minute.
- Do not get in the eyes.
- For best results, use fingertips and apply to affected areas with gentle pressure in a circular motion.
- Rinse off with warm water and pat dry with soft towel.
- If going outside, apply broad spectrum sunscreen SPF 15 or higher.
Other Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, FD&C Yellow # 5, Glycerine, Panthenol, Perlite, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate, Sodium Hydroxide, Water
Other Information
Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.
Principal Display Panel - 170 G Bottle Label
PHARMCO
SKINCARE LABS
Benzoyl Peroxide
Cleansing Gel 3.5%
Net wt. 6 oz. (170 g)
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