JACK NICKLAUS ANTISEPTIC HAND SANITIZER- alcohol liquid

Jack Nicklaus Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 60% W/W

Purpose

Antiseptic

Use

• For hand washing to decrease bacteria on the skin
• Recommended for repeated use

Warnings

Flammable, keep away from fire or flame.
For external use only

Do not use

• in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, DMDM hydantoin, fragrance (parfum), PEG-40 hydrogenated castor oil, sodium hydroxide, tocopheryl acetate, water.

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

JACK NICKLAUS ANTISEPTIC HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73025-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73025-001-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/01/2019

Labeler - Shalom International Corp (001384825)