HAND SANITIZER- ethanol gel 
Just Play, LLC

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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Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl alcohol 60%

Purpose

Antimicrobial

Uses

for hand sanitizing to decrease bacteria on the skin when soap and water are not available.

Warnings

For external use only-hands.

When using this product

avoid contact with eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if

irritation or redness develops.

Keep out of reach of children.

If swallowed, drink plenty of water & consult a physician or Poison Control Center immediately.

Other information

  • do not store above 105°F.
  • may discolor some fabrics.
  • harmful to wood finishes and plastics.

Directions

  • pour a small amount of gel onto palm of hand. Rub briskly over all surfaces of both hands until dry.
  • children under 6 should be supervised while using this product. Not recommended for infants.

Inactive Ingredients

carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water/aqua

*Effective at eliminating over 99.99% of many common household germs & bacteria in as little as 15 seconds.

Distributed by: Just Play
Deerfield Beach, FL
1-800-317-3245

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Bottle Label

HAND SANITIZER
LIGHT CITRUS SCENT

Kills 99.99% of Germs*
1.7 FL OZ (50 mL)

Principal Display Panel – Bottle Label
HAND SANITIZER 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76308-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL600 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76308-001-0150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/05/2011
Labeler - Just Play, LLC (961720922)
Establishment
NameAddressID/FEIBusiness Operations
Kingkey Daily Chemical Co., Ltd.545349263MANUFACTURE

Revised: 9/2011
Document Id: e2106329-5ca2-4274-9fe4-46e888ee08f8
Set id: e2106329-5ca2-4274-9fe4-46e888ee08f8
Version: 1
Effective Time: 20110905
 
Just Play, LLC