RELOVOX - renewing clarifying cleanser emulsion 
Transdermal Corp

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; Benzoyl Peroxide 2.5% (w/w)

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

Use for the management of acne and pimples and acne spots removal.

Indicated 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

Keep out of reach of children, store in a cool dry place at room temperature.

Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, ethyl alcohol, staeric acid, carbomer, sodium hydroxide, cocamidopropyl betain, sodium lauryl sulfate, castor oil,glycolic acid, salicylic acid, cocoa butter, vitamin E, vitamin A,  grape seeds oil.

•    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.

•    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

carton.jpg
image of carton label
RELOVOX 
renewing clarifying cleanser emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51350-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51350-005-061 in 1 CARTON
1NDC:51350-005-0530 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D03/31/2011
Labeler - Transdermal Corp (963383612)
Registrant - Transdermal Corp (963383612)
Establishment
NameAddressID/FEIBusiness Operations
Transdermal Corp963383612manufacture, label, analysis, pack

Revised: 3/2011
Document Id: ded8ab1d-4ff4-422e-95e5-0582e06888e4
Set id: ee049b13-d15a-495f-9c95-3f28c4161dae
Version: 1
Effective Time: 20110331
 
Transdermal Corp