EAAE DISINFECTANT- alcohol gel
JIANGSU HANHE DAILY CHEMICALS 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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Ethyl Alcohol 75% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

Non Medical. Flammable. Keep away from fire or flame

When using this product, do not use in or near eyes, In case of contact, rinse eyes thoroughly with water

Stop use and consult a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Directions

Put enough products on your plam to cover hands and rub hands together briskly until dry

Inactive ingredients

Water, Carbomer, Triethanolamine, Glycerol, Perfume, Castor Oil, Hydrogenated

image description

EAAE DISINFECTANT
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73027-208
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73027-208-01	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/21/2020

Labeler - JIANGSU HANHE DAILY CHEMICALS CO., LTD. (414409758)

Name	Address	ID/FEI	Business Operations
Establishment
JIANGSU HANHE DAILY CHEMICALS CO., LTD.		414409758	manufacture(73027-208)

Revised: 7/2020

Document Id: aaf65480-cbc7-0a72-e053-2a95a90ac76e

Set id: 097cef65-2b62-450e-9fa1-4d9fe829035b

Version: 1

Effective Time: 20200721

JIANGSU HANHE DAILY CHEMICALS CO., LTD.