NISC PURE HAND SANITIZER- ethyl alcohol gel

NISC Pure Hand Sanitizer by

Drug Labeling and Warnings

NISC Pure Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by NOWREZ & ISMAIL SHUKRI COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 75% By Volume

Purpose

Antimicrobial

INDICATIONS & USAGE

Use hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product  do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if  irritation or rash appears and lasts

Keep it out of the reach of children.

DOSAGE & ADMINISTRATION

Directions place enough product in your palm to thoroughly spread on both hands and rub into the skin untill dry children under 6 years of age should be supervised when using this product

STORAGE AND HANDLING

Other information  store below 106°F (41°C)
may discolor certain fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients: Aqua, Glycerin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Fragrance, Benzophenone- 3, D&C red no.33, FD&C blue no.1

SPL UNCLASSIFIED SECTION

Kills 99% of Germs

Anti-bacterial

Marine

Gel with Vitamin E

No water, No soap

Made in HKJ

Nowrez & Ismail Shukri Co. Amman - Jordan

Distributed by: Orchard Distributors LLC

21000 Coolidge Hwy

Oak Park, Michigan United State

48237-3222

Packaging

INGREDIENTS AND APPEARANCE

NISC PURE HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75771-243
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OXYBENZONE (UNII: 95OOS7VE0Y)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75771-243-04	110 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2020

Labeler - NOWREZ & ISMAIL SHUKRI COMPANY (534665497)

Establishment
Name	Address	ID/FEI	Business Operations
NOWREZ & ISMAIL SHUKRI COMPANY		534665497	manufacture(75771-243)