HAND SANITIZER- alcohol gel 
reBom 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.

----------

reBom Hand Sanitizer

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

Package Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60604-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60604-010-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/06/2020
2NDC:60604-010-37110 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/06/2020
Labeler - reBom Co., Ltd. (688733595)

Revised: 4/2020
Document Id: a2cd9df2-a81f-3f23-e053-2a95a90a7b95
Set id: a2cda367-14f4-b2ff-e053-2995a90a1f34
Version: 1
Effective Time: 20200413
 
reBom Co., Ltd.