Revitol
FDA Label NDC 24488-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Revitol Corporation for the product Revitol (NDC 24488-004). 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 ingredient..............................purpose:, use:, warnings:, do not use, when using this product:, stop use and ask a doctor if, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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Revitol_final_label (Revitol Final Label)

Revitol_final_label (Revitol Final Label)


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