HAND SANITISER by Jiangxi Iris Chemical Co.,Ltd HAND SANITISER gel

HAND SANITISER by

Drug Labeling and Warnings

HAND SANITISER by is a Otc medication manufactured, distributed, or labeled by Jiangxi Iris Chemical Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient[s]

Alcohol 75%v/v

Purpose

Antiseptic

Use[s]

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.

Do not use

in children less than 2 months of age

on open skin wounds

When using this product

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

STOP USE

Stop use and ask a doctor if irritation 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.

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 15-30C(59-86F).

Avoid freezing and excessive heat above 40C(104F).

Inactive ingredients

Water(Aqua) ,Carbomer,Triethanolamine,Tocopheryl Acetate.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITISER 
hand sanitiser gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74440-013
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74440-013-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
2	NDC: 74440-013-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
3	NDC: 74440-013-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
4	NDC: 74440-013-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
5	NDC: 74440-013-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/07/2020

Labeler - Jiangxi Iris Chemical Co.,Ltd (544366795)

Registrant - Jiangxi Iris Chemical Co.,Ltd (544366795)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Iris Chemical Co.,Ltd		544366795	manufacture(74440-013)