FDA Label for Micronized Bpo Wash

View Indications, Usage & Precautions

Micronized Bpo Wash 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.

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Drug Facts

  • Keep away from excessive heat or heat sources
  • Manufactured by:
    Pharmco Laboratories Inc. • Titusville, FL 32780
    www.pharmcolabs.com • 1.800.635.0712 • Reorder CPL02


Active Ingredient



Benzoyl Peroxide 5%


Purpose



Acne Treatment


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



Apply a quarter-sized amount to damp skin with gentle pressure and work into lather. Rinse with lukewarm water and pat dry with soft towel. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by a physician or skincare professional. If bothersome dryness or peeling occurs, reduce frequency of applications. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and consult a physician or skin care professional.


Other Ingredients



Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Panthenol, Phenoxyethanol, Polyethylene, Propylene Glycol, Sodium Hyaluronate, Sodium Hydroxide.


Other Information



Store at 20 - 25°C (68 - 77°F) Protect from heat. Keep container tightly closed.


Principal Display Panel - 3.9 Kg Bottle Label



PHARMCO
SKINCARE LABS

Micronized
BPO 5%
WASH

Net wt. 3.9 kg


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