HAND SANITIZER- ethanol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Just Play, LLC, Kingkey Daily Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

*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)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76308-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	600 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76308-001-01	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/05/2011

Labeler - Just Play, LLC (961720922)

Establishment
Name	Address	ID/FEI	Business Operations
Kingkey Daily Chemical Co., Ltd.		545349263	MANUFACTURE