Jack Nicklaus Antibacterial Hand Gel

Jack Nicklaus Antibacterial Hand Gel by

Drug Labeling and Warnings

Jack Nicklaus Antibacterial Hand Gel by is a Otc medication manufactured, distributed, or labeled by Shalom International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JACK NICKLAUS ANTIBACTERIAL HAND GEL- alcohol gel 
Shalom International Corp

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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Jack Nicklaus Antibacterial Hand Gel

Drug Facts

Active ingredient

Alcohol Denat. 62%

Purpose

Antibacterial 

Use

To decrease bacteria on the skin and clean hands. Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from flames.

When usingthis product 

do not get into eye. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation and redness develop or persists for more than 72 hours

Keep out of reach of children.

Directions

Apply to hands until thoroughly wet. Rub vigorously until dry.

Inactive ingredients

Water, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,DMDM Hydantoin, Fragrance (Parfum), Sodium Hydroxide, Tocopheryl Acetate.

Package Labeling:

Bottle

JACK NICKLAUS ANTIBACTERIAL HAND GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-142-6060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/202012/31/2021
Labeler - Shalom International Corp (001384825)

Revised: 3/2022
Document Id: dad19f01-3240-dd2e-e053-2995a90acec3
Set id: 92b96ee0-2416-442d-afbb-ab08cae4881d
Version: 3
Effective Time: 20220322