RELOVOX- renewing clarifying cleanser emulsion

Relovox by

Drug Labeling and Warnings

Relovox by is a Otc medication manufactured, distributed, or labeled by Transdermal Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient; Benzoyl Peroxide 2.5% (w/w)

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 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.

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.

    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

PRINCIPAL DISPLAY PANEL

carton.jpg

INGREDIENTS AND APPEARANCE

RELOVOX 
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