CLEAR DEFENSE CITRUS SUNRISE- alcohol gel 
Melaleuca Inc

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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Active ingredient

Ethyl alcohol 62%

Purpose

Antimicrobial

Uses

■ for handwashing to reduce bacteria on the skin

■ recommended for repeated use

Warnings: For external use only

Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions ■ place enough product in your palm to thoroughly cover your hands ■ rub hands together briskly until dry ■ children under 6 years of age should be supervised when using this product

Other information ■ store below 82°F (28°C) ■ may discolor certain fabrics or surfaces ■ alcohol derived from corn

Inactive ingredients water, gylcerin, xylitol, anhydroxylitol, xylitylglucoside, carbomer, aminomethyl propanol, fragrance, aloe barbadensis leaf extract, melaleuca alternifolia leaf oil, polysorbate 20, tocopheryl acetate, jojoba esters, butyrospermum parkii, theobroma cacao seed butter, mangifera indica seed butter, iron oxides, red 30, talc

Citrus Sunrise label

CLEAR DEFENSE  CITRUS SUNRISE
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-252
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL36.58 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE 
ALOE VERA LEAF 
AMINOMETHYLPROPANOL 
ANHYDROXYLITOL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
COCOA BUTTER 
FERRIC OXIDE RED 
GLYCERIN 
MANGIFERA INDICA SEED BUTTER 
POLYSORBATE 20 
D&C RED NO. 30 
SHEA BUTTER 
TALC 
TEA TREE OIL 
WATER 
XYLITOL 
XYLITYLGLUCOSIDE 
Packaging
#Item CodePackage Description
1NDC:54473-252-0259 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/01/201112/01/2012
Labeler - Melaleuca Inc (139760102)
Registrant - Melaleuca Inc (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca Inc787086842manufacture(54473-252)

Revised: 03/2013
 
Melaleuca Inc