Acne Forte Acne Treatment Cream
FDA Label NDC 52063-709

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gscm Ventures Inc. Dba Revitol for the product Acne Forte Acne Treatment Cream (NDC 52063-709). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses:, warnings:, when using this product, do not use if you, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzoyl peroxide 5.00%

Purpose

Acne Treatment

Uses:

  • For the treatment of acne.

Warnings:

For external use only

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 wih 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.

Stop Use And Ask A Doctor If

irritation becomes severe.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

  • 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, 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

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, ALoe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Betula Alba (Brich) Extract, Camellia Sinensis (Green Tea) Extract, camellia Sinensis (White Tea) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Oil, DMDM Hydantoin, Glycerin, Hamamelis Virginiana (Witch Hazel), Iodopropynyl Butylcarbamate, Manuka Honey, Methylisothiazolinone, Parfum (Fragrance), Propylene Glycol, Melaleuca Alternifolia (Tea Tree) Oil, Polysorbate-20, Salix Nigra (Willow) Bark Extract, Saccharum Officinarum (Sugar Cane) Extract, Salvia Officinalis (Sage) Extract, Sodium Citrate, Sodium Hyaluronate, Triethanolamine, Vaccinium Myrtillus (Bilberry Extract, Xanthan Gum.

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