CLEAR DEFENSE CITRUS SAGE- ethyl 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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Clear Defense Citrus Sunrise

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

Citrus Sage Label

CLEAR DEFENSE  CITRUS SAGE
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-258
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL36.58 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
COCOA BUTTER (UNII: 512OYT1CRR)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
SHEA BUTTER (UNII: K49155WL9Y)  
TALC (UNII: 7SEV7J4R1U)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-258-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/15/2014
Labeler - Melaleuca Inc (139760102)
Registrant - Melaleuca Inc (079711683)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca Inc079711683manufacture(54473-258)

Revised: 2/2018
Document Id: 65e42868-4672-5611-e053-2991aa0ab48b
Set id: cdeed0d7-f1f7-4b72-8d69-935baedafab7
Version: 4
Effective Time: 20180223
 
Melaleuca Inc