CLEAR DEFENSE- 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 Hand Gel 9oz

Active ingredient
Ethyl Alcohol 62%

Purpose
Antimicrobial

Uses

Warnings
For External use only
Highly flammable. Keep away from fire or flame.

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

Other information

Other information

Inactive ingredients
water, glycerin, xylitol, anhydroxylitol, xylitylglucoside, carbomer, aminomethyl propanol, fragrance, aloe barbadensis leaf extract, melaleuca alternifolia (tea tree) leaf oil, polysorbate 20, tocopheryl acetate

image of label

CLEAR DEFENSE 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-296
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL150.97 g  in 266 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
TEA TREE OIL (UNII: VIF565UC2G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-296-09266 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
2NDC:54473-296-2471 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
3NDC:54473-296-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
4NDC:54473-296-1853 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/09/2010
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079711683manufacture(54473-296)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca - TN805617610manufacture(54473-296)

Revised: 1/2023
Document Id: f205510b-90fb-770f-e053-2995a90a7fb0
Set id: 25638ab1-afa2-4de5-af20-cdb0a08a0c50
Version: 6
Effective Time: 20230111
 
Melaleuca, Inc.