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.

----------

Clear Defense 2.4 oz Content of Label

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

image of label

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

CLEAR DEFENSE 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-141
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL39.184 g  in 70 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Tea Tree Oil (UNII: VIF565UC2G)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-141-0370 mL in 1 BOTTLE
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.139760102manufacture

Revised: 1/2011
Document Id: a6c8846f-00a3-45d1-aee0-664fc4839de7
Set id: f2032f43-e93f-4260-aabf-dc5fb769c4d2
Version: 1
Effective Time: 20110117
 
Melaleuca, Inc.