WASH FREE DISINFECTION GEL- alcohol gel
Guangzhou Ruihe Medical 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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Active Ingredient(s)

Alcohol 75% v/v

Purpose

Antiseptic

Use

Hand sanitizing for intact skin

Warnings

External use, keep out of reach of children, avoid eyes and ear.
Use with caution for who allergic to ethanol.
Keep away from light, sealed, moisture-prood, store in a cool, dry place.
Flammable. Keep away from fire or flame

Do not use

in children less than 2 months of age
on open skin wounds

Pruritus, redness, and swelling of hands, allergy, etc.

Keep out of reach of children.

Directions

Wet hand with proper amount of the product, and keep the liquid for 1 minute until the liquid covers the whole hand and dry.
Children under 6 years of age when using this product to avoid swallowing.

Other information

Do not store above 40C. May discolor some fabrics and surfaces.
Store between 15-30C

Inactive ingredients

Water, Triethanolamine, Carbomer

Package Label - Principal Display Panel

label

WASH FREE DISINFECTION GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74180-001
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
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74180-001-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
2	NDC:74180-001-02	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
3	NDC:74180-001-03	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
4	NDC:74180-001-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Guangzhou Ruihe Medical Technology Co.,Ltd. (419114912)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Ruihe Medical Technology Co.,Ltd.		419114912	manufacture(74180-001)