INSTANT HAND SANITIZER- alcohol gel 
China Ningbo Shangge Cosmetic Technology Corp.

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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Active Ingredient                              Purpose

Ethyl Alcohol 62.0%......................Antimicrobial

XtraCare Instant Hand Sanitizer - Original

Kills 99.9% of Germs with Moisturizers & Vitamin E

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

USE: 

  • hand sanitizer to help reduce bacteria on the skin that may cause disease

Warnings:

for external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Directions:

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • children under 6 years of age should be supervised by an adult when using.

Inactive ingredients:

carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water, fragrance.

bottle label

package label

INSTANT HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-018
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL6 mL  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:58503-018-022 in 1 PACKAGE
1NDC:58503-018-0110 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/05/2013
Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-018)

Revised: 07/2013
Document Id: 6365fff7-ae9c-4acb-909a-dce1a5fcdc15
Set id: 03002937-51c3-4cd5-87ad-064b973241f7
Version: 1
Effective Time: 20130705
 
China Ningbo Shangge Cosmetic Technology Corp.