HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by reBom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand Sanitizer to help decrease bacteria on the skin. For use when soap and water are not available.

Do not use

■ In children less than 2 months of age

■ on open skin wounds

Warnings

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

When using this product

Keep out of eyes ears an mouth . In case of eye contact immediately flush eyes throughly with water

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

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions

■ Place enough product on your hands to cover all surfaces. Rub hands together until dry ■ Supervise children under 6 years of age when using this product to aviod swallowing.

Other information

■ Store between 15º-30ºC (59º-89ºF) ■ Avoid freezing and excessive heat above 40ºC (140ºF) ■ May discolor fabrics or surfaces

Inactive Ingredients

carbomer, glycerin, triethanolamine, water

Package Label

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60604-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60604-010-16	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/06/2020
2	NDC: 60604-010-37	110 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/06/2020

Labeler - reBom Co., Ltd. (688733595)