Hand Sanitizer by Fujian Jinghua Biotechnology Co.,Ltd. Hand Sanitizer Gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fujian Jinghua Biotechnology Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer gel 
Fujian Jinghua Biotechnology 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 Gel

Active Ingredient(s)

Ethyl alcohol 70%v/v.

Purpose

Antiseptic

USES

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.

When Using This Product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

INACTIVE INGREDIENTS

WATER, CARBOMER, TETRAHYDROXYPROPYL ETHYLENEDIAMINE, GLYCERIN, ETHYLHEXYLGLYCERIN, PANTHENOL

in children less than 2 months of age
on skin wounds

Stop use and ask a doctor if imitation 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.

Package Label - Principal Display Panel

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75438-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETOL (UNII: Q4R969U9FR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75438-003-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2020
2	NDC: 75438-003-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2020
3	NDC: 75438-003-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2020
4	NDC: 75438-003-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/25/2020	01/21/2021

Labeler - Fujian Jinghua Biotechnology Co.,Ltd. (416242797)

Establishment
Name	Address	ID/FEI	Business Operations
Fujian Jinghua Biotechnology Co.,Ltd.		416242797	manufacture(75438-003)

Revised: 1/2021

Document Id: b96498d2-a8cb-44de-e053-2995a90a8d76

34390-5

Set id: a7c69f71-390c-197b-e053-2a95a90a225c

Version: 2

Effective Time: 20210121