HAND SANITIZER- alcohol gel 
Kareway Product, 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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Drug facts

Active Ingredient

Ethyl Alcohol  62%    

Purpose

Antiseptic

Keep out of reach of children

In case of a accidental ingestion, seek professional assistance or contact a Poison control Center immediately.

Uses

Warnings

For external use only-hands.
Flammable. Keep away from hear or flame.

When using this product

  • Keep out of eyes. In case of contact with eyes, flush throughly with water.
  • Avoid contact with broken skin.

Stop use and ask a doctor if

skin irritation developes

Directions

Other information

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Isopropyl Alcohol, Sodium Hydroxide, Isopropyl Myristate, Tocopheryl Acetate, Aloe Vera Extract

image of bottle label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0487
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0487-22 in 1 BLISTER PACK
159.2 mL in 1 BOTTLE
2NDC:67510-0487-81 in 1 BLISTER PACK
2236 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/07/2013
Labeler - Kareway Product, Inc. (121840057)
Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(67510-0487)

Revised: 10/2013
Document Id: 16bde801-42e2-4993-bebf-1a26e18394e1
Set id: a1c9c574-2dbb-438c-a8de-569d15f51460
Version: 1
Effective Time: 20131008
 
Kareway Product, Inc.