HAND SANITIZER - alcohol liquid 
Ningbo Kleen Products Co., Ltd.

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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Label Content

Active Ingredient:      Ethyl Alcohol   62%

Purpose:  Antiseptic

Uses:    To decrease bacteria on the skin that could cause disease



Warnings: For external use only-hands. Flammable. Keep away from heat and flame.

When using this product. Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest

Stop use and see a doctor if skin irritation develops.

Keep out of reach of children. If swallowed, get medical help or call a poison control center right away

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

Other Information

Do not store above 105F

May discolor some fabric

Harmful to wood finishes and plastics


Directions: Wet hands thoroughly with products and allow to dry without wiping. For children under 6 use only under adult supervision. Not recommended for infants

labelabel

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52174-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 36.43 g  in 100 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.02 g  in 100 g
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.2 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK) 0.2 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 0.5 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52174-002-0110 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/08/2010
Labeler - Ningbo Kleen Products Co., Ltd. (529352816)
Registrant - Ningbo Kleen Products Co., Ltd. (529352816)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Kleen Products Co., Ltd.529352816manufacture

Revised: 9/2010
Document Id: 50016185-3b35-4112-870a-36545dc5c1d1
Set id: cd3179cf-df58-4412-bf7f-081cb109c2bf
Version: 1
Effective Time: 20100908
 
Ningbo Kleen Products Co., Ltd.