HPY INSTANT HAND SANITIZER- alcohol gel 
HPY BIOTECH 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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HPY Instant Hand Sanitizer

Active Ingredient(s)

ethanol 50% - 60% w/w.

phenoxyethanol 0.8% - 1% w/w.

Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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.

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

glycerin, purified water USP

Package Label - Principal Display Panel

50 mL NDC: 80222-002-01 label

HPY INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80222-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80222-002-0150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/20/2020
2NDC:80222-002-02100 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/20/2020
3NDC:80222-002-03500 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/20/2020
4NDC:80222-002-0450 mL in 1 TUBE; Type 0: Not a Combination Product08/20/2020
5NDC:80222-002-05100 mL in 1 TUBE; Type 0: Not a Combination Product08/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/20/2020
Labeler - HPY BIOTECH CO.,LTD. (413571769)
Registrant - HPY BIOTECH CO.,LTD. (413571769)
Establishment
NameAddressID/FEIBusiness Operations
HPY BIOTECH CO.,LTD.413571769manufacture(80222-002) , label(80222-002)

Revised: 8/2020
Document Id: add7a734-b224-2827-e053-2a95a90a9532
Set id: add7ba5e-c798-7377-e053-2995a90acd58
Version: 1
Effective Time: 20200827
 
HPY BIOTECH CO.,LTD.