Label: REVITOL ACNE TREATMENT- benzoyl peroxide cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated April 14, 2011
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- Active Ingredient..............................Purpose:
- Do not use
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
- Keep out of reach of children.
- 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:
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:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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