FDA Label for Revitol Acne Treatment

View Indications, Usage & Precautions

Revitol Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Revitol Corporation. 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.

Active Ingredient..............................Purpose:



Benzoyl Peroxide 5%..............................Acne Medication


Use:



For the treatment of acne.


Warnings:



For external use only.


Do Not Use



if you have sensitive skin or are sensitive to benzoyl peroxide.


When Using This Product:



  • Avoid unnecessary sun exposure and use sunscreen.
  • Keep away from eyes, lips and mouth areas.
  • Using other topical acne drug at the same time or right after may increase dryness or irritation of skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Irritation may develop, such as redness, burning, itching, peeling or possibly swelling.
  • It may bleach hair or dye fabrics.

Stop Use And Ask A Doctor If



irritation becomes severe and continues


Keep Out Of Reach Of Children.



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


Directions:



  • Cleanse the skin thoroughly before applying  medication
  • Cover the entire affected area with a thin layer one to three times a day
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two ore three times daily if needed or as directed by a doctor. If bothersome drying or peeling occurs, reduce application to once a day or every other day.
  • If going outside, use a sunscreen. Allow Acne Treatment Cream to dry, then follow directions in sunscreen labeling if sensitivity develops, discontinue use of both products and ask a doctor.

Other Information:



Enter section text here


Inactive Ingredients



Water, Propylene Glycol, Carbomer  Allantoin, Triethanolamine, Sodium Hyaluronate, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Betula Alba (Birch Sap) Juice, Epilobium Angustifolium (Willowherb) Flower/Leaf/Stem Extract, Vaccinium Myrtillus (Bilberry) Extract, Saccharum Officinarum (Sugar Cane) Extract, Citrus Aurantius Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Peel, Salvia Officinalis (Sage) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Honey Extract, Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Xathan Gum, DMDM Hydantoin, Benzyl Alcohol, Sodium Citrate, Sodium Hydroxide


Questions Or Comments:



1-800-756-4120 Mon - Fri 9AM to 5PM PST - Revitol Corp., 2049 North Lincoln Street, Burbank, CA 91504 - Made in the USA


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