Hand Sanitizer by TONGLU ELINK MEDICAL SUPPLY CO.,LTD

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by TONGLU ELINK MEDICAL SUPPLY CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
TONGLU ELINK MEDICAL SUPPLY 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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Drug Facts

Active Ingredient(s)

Ethyl Alcohol 62%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Avoid contact with face,eyes,and broken skin.In case of eye contact,flush with plenty of water and seek medical advice.

Stop use and ask a doctor if irritation or redness develops.

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 rub into skin until dry.Children under 6 years of age should be supervised by an adult when using.

Inactive ingredients

Water(Aqua),Aloe Barbadensis Leaf Juice, Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate(Vitamin E), Triethanolamine.

Package Label - Principal Display Panel

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78438-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78438-001-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/03/2020	01/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/03/2020	01/06/2021

Labeler - TONGLU ELINK MEDICAL SUPPLY CO.,LTD (554535191)

Registrant - TONGLU ELINK MEDICAL SUPPLY CO.,LTD (554535191)

Establishment
Name	Address	ID/FEI	Business Operations
TONGLU ELINK MEDICAL SUPPLY CO.,LTD		554535191	manufacture(78438-001)

Revised: 1/2021

Document Id: b471a07a-4560-d553-e053-2995a90ae75f

34390-5

Set id: a722855d-8696-e4ed-e053-2a95a90a89bf

Version: 2

Effective Time: 20210106