Hand Sanitizer Antiseptic Gel 75% Alcohol

Hand Sanitizer Antiseptic 75 Alcohol by

Drug Labeling and Warnings

Hand Sanitizer Antiseptic 75 Alcohol by is a Otc medication manufactured, distributed, or labeled by Fujian Kangchen Daily Necessities Co. Ltd, Quanzhou Zhezhixin Biochemical Technology Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER ANTISEPTIC 75 ALCOHOL- alcohol gel 
Fujian Kangchen Daily Necessities 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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Hand Sanitizer Antiseptic Gel 75% Alcohol

Drug Facts

Active ingredient

Alcohol 75%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

in the eyes

Stop use and ask a doctor if:

• irritation and redness develop
• condition persista for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping

Other information

Shelf life of 24 months

Inactive ingredients

Glycerin, Water

Package Labeling:

HAND SANITIZER ANTISEPTIC 75 ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75793-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75793-010-00	1 in 1 BOX	08/01/2020	12/31/2022
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2020	12/31/2022

Labeler - Fujian Kangchen Daily Necessities Co. Ltd (415721242)

Establishment
Name	Address	ID/FEI	Business Operations
Quanzhou Zhezhixin Biochemical Technology Co., LTD		551828815	manufacture(75793-010)

Revised: 10/2022

Document Id: ebd54e1d-bbac-2ca0-e053-2a95a90a50a5

34390-5

Set id: a4963182-9107-40d7-9c47-f6aea9c8c9ec

Version: 2

Effective Time: 20221025

 

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