74% ISOPROPYL ALCOHOL HAND SANITIZER SOLUTION- hand sanitizer solution
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.

----------

Active Ingredient(s)

Isopropyl Alcohol 74% 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

in children less than 2 months of age
on open skin wounds

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

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, sterile distilled water.

Package Label - Principal Display Panel

60 ml NDC: 78220-002-01 Package Label

74% ISOPROPYL ALCOHOL HAND SANITIZER SOLUTION
hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78220-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	44.4 mL in 60 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.42 mL in 60 mL
WATER (UNII: 059QF0KO0R)	15.18 mL in 60 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78220-002-01	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/28/2020

Labeler - Jiaozi Chemical (guangzhou) Pty Ltd (679755413)

Registrant - Jiaozi Chemical (guangzhou) Pty Ltd (679755413)

Name	Address	ID/FEI	Business Operations
Establishment
Jiaozi Chemical (guangzhou) Pty Ltd		679755413	manufacture(78220-002)