HAND SANITIZER GEL- alcohol gel

Hand Sanitizer gel by

Drug Labeling and Warnings

Hand Sanitizer gel by is a Otc medication manufactured, distributed, or labeled by ZHEJIANG RIFESHOW COSMETICS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75%±5% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer gel

Use

Hand Sanitizer to help reduce bacteria on skin

Warnings

For external use only. Flammable. Keep away from fire or flame

Do not use

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

WHEN USING

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

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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

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

Other information

Store between 110℉(43℃)

May discolor certain fabrics

Inactive ingredients

Deionized water,Glycerol, carbome,Trithanolamine

Direction

Put enough product in your palm to cover hands and rub hands together briskly until dry.Children under 6 years of age should be supervised when using.Easy to use at your home,office or while travelling

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56084-019
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
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56084-019-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/31/2020

Labeler - ZHEJIANG RIFESHOW COSMETICS CO.,LTD (560843477)

Establishment
Name	Address	ID/FEI	Business Operations
ZHEJIANG RIFESHOW COSMETICS CO.,LTD		560843477	manufacture(56084-019)