Jack Nicklaus hand sanitizer

Jack Nicklaus hand sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

JACK NICKLAUS HAND SANITIZER- 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 hand sanitizer

Drug Facts

Active Ingredients

Alcohol Denat. 62%

Purpose

Antibacterial

Uses

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease.
  • Recommended for repeated use.

Warnings

  • Flamable. Keep away from fire or flame.
  • For external use only

When using this product

do not use in or near the eyes. Incase of contact, rinse eyes thoroughly with water.

Stop use & ask a doctor if

irritation or rash appears & lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply enough product to thoroughly cover hands.
  • Rub hands together briskly until dry.

Other Information

  • Do not store above 110°F (43°C).
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

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

Questions?

  • Call 212-391-6970

Package Labeling

Label5

JACK NICKLAUS HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-063
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
WATER (UNII: 059QF0KO0R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-063-00770 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/30/202012/31/2021
Labeler - Shalom International Corp (001384825)

Revised: 3/2022
Document Id: d929f7d0-d8b8-523f-e053-2995a90a9952
Set id: 0ed5e5da-888f-4f4d-b990-828a3e64236a
Version: 3
Effective Time: 20220301