Label: RELOVOX- renewing clarifying cleanser emulsion
- Category: HUMAN OTC DRUG LABEL
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 March 31, 2011
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- ACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel. Children under 2 years of age, consult your doctorIndicated and use for the management of acne and removal of the acne spots, Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel.Children under 2 years of age, consult your doctor
DO NOT USE
• Ask your doctor if you using other acne medications
• Do not use if you are allergic to Benzoyl Peroxide
• Do not use in or near the eyes
• Do not use in large amount particularly over the raw surfaces or blisters
Stop use and Ask Doctors if
• Allergic reactions occurs
• Condition worsen and does not improve
• Excessive dryness and peeling of skin occurs
• itching, redness, burning , swelling or other symptoms occurs
• Keep both used and unused medicine out of the reach of children or pets
• If swallowed get medical attention right away Call your doctor immediately.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
renewing clarifying cleanser emulsion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51350-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ISOPROPYL ALCOHOL (UNII: ND2M416302) ZINC ACETATE (UNII: FM5526K07A) ALCOHOL (UNII: 3K9958V90M) ALOE (UNII: V5VD430YW9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCOLIC ACID (UNII: 0WT12SX38S) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CASTOR OIL (UNII: D5340Y2I9G) SODIUM HYDROXIDE (UNII: 55X04QC32I) SALICYL ALCOHOL (UNII: FA1N0842KB) SALICYLIC ACID (UNII: O414PZ4LPZ) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51350-005-06 1 in 1 CARTON 1 NDC:51350-005-05 30 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 03/31/2011 Labeler - Transdermal Corp (963383612) Registrant - Transdermal Corp (963383612) Establishment Name Address ID/FEI Business Operations Transdermal Corp 963383612 manufacture, label, analysis, pack