Revitol Acne Treatment

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 2.95mL in 59mL
Labeler: Revitol Corporation
NDC Code: 24488-004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts:

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

Placeholder Text



REVITOL  ACNE TREATMENT
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOIC ACID) BENZOYL PEROXIDE2.95 mL  in 59 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE C 
ALLANTOIN 
TROLAMINE 
HYALURONATE SODIUM 
TEA TREE OIL 
BETULA PUBESCENS RESIN 
EPILOBIUM ANGUSTIFOLIUM LEAF 
BILBERRY 
SUGARCANE 
ORANGE 
LEMON PEEL 
SAGE 
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 
HONEY 
ALOE VERA LEAF 
GREEN TEA LEAF 
XANTHAN GUM 
DMDM HYDANTOIN 
BENZYL ALCOHOL 
SODIUM CITRATE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:24488-004-2059 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D04/14/2011
Labeler - Revitol Corporation (961956229)
Registrant - Creation's Garden Natural Products (961956229)
Establishment
NameAddressID/FEIOperations
Creation's Garden Natural Products961956229manufacture

Revised: 04/2011
 
Revitol Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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