HAND SANITIZER- hand sanitizer gel
GUANGZHOU YIQI TECHNOLOGY 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

Active Ingredient

Ethyl alcohol 75%(V/V)

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available

WARNINGS

Flammable,keep away from fire or flame.For external use only.

When using this product

do not use in or near the eyes, In case of contact, rinse eyes thoroughly with water.Stop use and ask doctor if irritation or rash

appears and lasts.Keep out of reach for children.If swallowed,get medical help or contact a Poison Control Center right away.

Directions

Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other information

Store below 106°F.(41℃)

May discolor certain fabrics or surfaces.

Inactive Ingredients

Water(Aqua) , Carbomer,Glycerin, Trolamine.

Package Label - Principal Display Panel

60 ml label 100 ml label 120 ml label 250 ml label 300 ml label 500 ml label 750 ml label 1000 ml label 4000 ml label 5000 ml label

HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78295-003
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 HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78295-003-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
2	NDC:78295-003-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
3	NDC:78295-003-03	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
4	NDC:78295-003-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
5	NDC:78295-003-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
6	NDC:78295-003-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
7	NDC:78295-003-07	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
8	NDC:78295-003-08	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
9	NDC:78295-003-09	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
10	NDC:78295-003-10	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/18/2020

Labeler - GUANGZHOU YIQI TECHNOLOGY CO.,LTD (544707398)

Registrant - GUANGZHOU YIQI TECHNOLOGY CO.,LTD (544707398)

Name	Address	ID/FEI	Business Operations
Establishment
GUANGZHOU YIQI TECHNOLOGY CO.,LTD		544707398	manufacture(78295-003)