INSTANT HAND SANITIZER - ORIGINAL- ethyl 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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Instant Hand Sanitizer - Original

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: 

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:

Inactive ingredients:

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

bottle label

package label

INSTANT HAND SANITIZER - ORIGINAL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL33 mL  in 53 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-017-022 in 1 PACKAGE07/05/2013
1NDC:58503-017-0153 mL in 1 BOTTLE; Type 0: Not a Combination Product
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(58503-017)

Revised: 11/2022
Document Id: edb1a6e6-d7ff-3e5d-e053-2a95a90a5bda
Set id: 74b3da8c-efff-4a96-867a-d7aa258502b2
Version: 3
Effective Time: 20221117
 
China Ningbo Shangge Cosmetic Technology Corp.