THRIVE HEALTH HAND SANITIZER- ethyl alcohol gel 
Sanrace Biotechnology 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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Thrive Health Hand Sanitizer with Aloe

Drug Facts

Active Ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Inactive Ingredients: Water, Glycerin, Propylene glycol, Carbomer, Aloe vera extract

Packaging

Label Sample

THRIVE HEALTH HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75448-322
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75448-322-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC:75448-322-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
3NDC:75448-322-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/29/2020
Labeler - Sanrace Biotechnology Co., Ltd. (543000938)
Establishment
NameAddressID/FEIBusiness Operations
Sanrace Biotechnology Co., Ltd.543000938manufacture(75448-322)

Revised: 5/2020
Document Id: 4648f8dc-4142-4201-8cdf-4f989b7941c2
Set id: 411d6f26-2f1c-4861-91e6-8c74489b8b68
Version: 1
Effective Time: 20200520
 
Sanrace Biotechnology Co., Ltd.