Rinse-Free Hand Disinfection Gel

Rinse Free Hand Disinfection by

Drug Labeling and Warnings

Rinse Free Hand Disinfection by is a Otc medication manufactured, distributed, or labeled by Winner Medical (Jiayu) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RINSE FREE HAND DISINFECTION- alcohol gel 
Winner Medical (Jiayu) 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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Rinse-Free Hand Disinfection Gel

Drug Facts

Active Ingredient

Alcohol: 75% (v/v)

Purpose

Antimicrobial

Uses

It is suitable for quick disinfection of daily hand hygiene.

Warnings

• External use only. Avoid contact with eyes.
• Flammable. Keep away from heat or flame.

Keep away from children.

1. If swallowed, Get medical help right away.

Stop use and ask a doctor 

• if irritation, sensitization, or allergic reaction occurs.

Do not use

• if you are allergic to alcohol or any other ingredient in this product.

Do not use

• In children less than 2 months of age.
• On open skin wounds.

Directions

Take an appropriate amount (1-3 ml) of product to moisten your hands and rub for 1 minute until the liquid covers your hands, wait for drying and do not wash with water.

Other Information

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

Inactive ingredients

Aqua, Glycerin, Carbomer, Triethanolamine.

Package Labeling:50ml

Package Labeling:60ml

Package Labeling:500ml

Package Labeling:1000ml

RINSE FREE HAND DISINFECTION 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71870-004
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71870-004-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020	10/30/2021
2	NDC: 71870-004-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020	10/30/2021
3	NDC: 71870-004-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020	10/30/2021
4	NDC: 71870-004-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020	10/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/05/2020	10/30/2021

Labeler - Winner Medical (Jiayu) Co., Ltd. (530058569)

Revised: 10/2021

Document Id: cea40e40-0c93-509b-e053-2995a90a931f

34390-5

Set id: 9bfc5a0f-4611-42c4-9342-0fb52ac7f154

Version: 2

Effective Time: 20211018