Clear Defense Hand Gel 9oz Content of Label

Clear Defense Hand Gel 9oz Content of Label

Drug Labeling and Warnings

Drug Details

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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 Content of Label

Active ingredient
Ethyl Alcohol 62%

Purpose
Antimicrobial

Uses

  • to reduce bacteria on the skin
  • recommended for repeated use

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

  • dispense a generous amount of gel in your palm
  • spread gel over your hands until thoroughly coated
  • rub your hands together briskly until dry
  • children under 6 should be supervised when using this product

Other information

  • store below 82°F (28°C)

Other information

  • may discolor certain fabrics or surfaces

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
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)

Revised: 2/2018
 
Melaleuca, Inc.


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