REVITOL ACNE TREATMENT- benzoyl peroxide  cream 
Revitol Corporation

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.

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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:

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:

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  ACNE TREATMENT
benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24488-004
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOYL PEROXIDE 2.95 mL  in 59 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ALLANTOIN (UNII: 344S277G0Z)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TEA TREE OIL (UNII: VIF565UC2G)  
BETULA PUBESCENS RESIN (UNII: 9G931M6I4G)  
EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
BILBERRY (UNII: 9P2U39H18W)  
SUGARCANE (UNII: 81H2R5AOH3)  
ORANGE (UNII: 5EVU04N5QU)  
LEMON PEEL (UNII: 72O054U628)  
SAGE (UNII: 065C5D077J)  
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
HONEY (UNII: Y9H1V576FH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24488-004-20 59 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 04/14/2011
Labeler - Revitol Corporation (961956229)
Registrant - Creation's Garden Natural Products (961956229)
Establishment
Name Address ID/FEI Business Operations
Creation's Garden Natural Products 961956229 manufacture

Revised: 4/2011
Document Id: 0a03c383-b407-4022-9396-4a5fa1d3397f
Set id: 41967aa8-25ae-4478-951b-f14eb51fb0c5
Version: 1
Effective Time: 20110414
 
Revitol Corporation