HAND SANITIZER ANTIBACTERIAL VITAMIN E- ethyl alcohol liquid 
China Ningbo Shangge Technology 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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Xtra Care Hand sanitizer with vitamin E

Ethyl Alcohol 70.0% v/v

Antimicrobial

For external use only.

Flammable, keep away from fire or 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.

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

Other Information

water, glycerin, carbomer, fragrance, triethanolamine, propylene glycol, tocopheryl acetate, aloe barbadensis leaf juice

label 2label

HAND SANITIZER ANTIBACTERIAL  VITAMIN E
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-133-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
2NDC:58503-133-02177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/05/2020
Labeler - China Ningbo Shangge Technology Co., Ltd. (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Technology Co., Ltd.529287434manufacture(58503-133)

Revised: 5/2020
Document Id: a68fc23d-5837-37b7-e053-2a95a90ad36b
Set id: a3478036-712e-603a-e053-2995a90a4b08
Version: 2
Effective Time: 20200526
 
China Ningbo Shangge Technology Co., Ltd.