INSTANT HAND SANITIZER - COCOA BUTTER- 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 IngredientPurpose

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

Health Care Instant Hand Sanitizer - Ice Clear - Extra Enriched with Vitamin E Bead & Aloe

Kills 99.9% of Germs without water or towels!

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

USE: 

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use

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
  • supervise children in the use of this product

Inactive ingredients:

aloe vera leaf juice, carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water.

Other information:

  • store at 20oC to 25oC (68o to 77oF)
  • may discolor certain fabrics

bottle label

INSTANT HAND SANITIZER - COCOA BUTTER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL147 mL  in 237 mL
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER 
CARBOMER HOMOPOLYMER TYPE B 
GLYCERIN 
PROPYLENE GLYCOL 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:58503-015-01236 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(58503-015)

Revised: 07/2013
Document Id: bde3c20a-7401-4f23-8e08-7759cb737c3f
Set id: c80bd552-66cb-48d2-a138-1795681d7052
Version: 1
Effective Time: 20130705
 
China Ningbo Shangge Cosmetic Technology Corp.