75% ALCOHOL HAND SANITIZER GEL- hand sanitizer gel 
Jiaozi Chemical (guangzhou) Pty 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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Active Ingredient(s)

Alcohol 75% v/v. 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

aloe, carbomer, glycerin, sterile distilled water, triethanolamine.

Package Label - Principal Display Panel

60 mL NDC: 78220-001-01 Package Label

75% ALCOHOL HAND SANITIZER GEL 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78220-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL45 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.1542 mL  in 60 mL
ALOE (UNII: V5VD430YW9) 0.0516 mL  in 60 mL
GLYCERIN (UNII: PDC6A3C0OX) 2.04 mL  in 60 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.1542 mL  in 60 mL
WATER (UNII: 059QF0KO0R) 12.6 mL  in 60 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78220-001-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/28/2020
Labeler - Jiaozi Chemical (guangzhou) Pty Ltd (679755413)
Registrant - Jiaozi Chemical (guangzhou) Pty Ltd (679755413)
Establishment
NameAddressID/FEIBusiness Operations
Jiaozi Chemical (guangzhou) Pty Ltd679755413manufacture(78220-001)

Revised: 6/2020
Document Id: a724ef9c-2e0a-6db3-e053-2a95a90aec5a
Set id: a724f378-56a4-2d14-e053-2995a90a3718
Version: 3
Effective Time: 20200602
 
Jiaozi Chemical (guangzhou) Pty Ltd