GEL HAND SANITIZER- moisturizing gel hand sanitizer gel

Gel Hand Sanitizer by

Drug Labeling and Warnings

Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by BuckAirways Inc., Berdor Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic; Hand Sanitizer

Uses

To decrease bacteria on the skin that could cause disease. Reccomended for repeated use. For use when soap and water are not available.

Warnings

For external use only: Hands. Flammable, keep aware from fire or flame.

Do not use

In children less than 2 months of age. On open skin or wounds.

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor ir irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Purified Water USP, Glycerin, Tocopheryl Acetate (Vitamin E), Panthenol (Vitamin B-6), Polyacrylate Crosspolymer-6, Fragerence

Packaging Label - Principal Display Panel

59 ML NDC Code 75396-315-17

FRONT

BACK

118ML NDC Code 75396-315-18

FRONT

BACK

3785ML NDC Code 75396-315-19

FRONT

BACK

INGREDIENTS AND APPEARANCE

GEL HAND SANITIZER 
moisturizing gel hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75396-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
DEXPANTHENOL (UNII: 1O6C93RI7Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75396-315-17	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/25/2020
2	NDC: 75396-315-18	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/25/2020
3	NDC: 75396-315-19	3785 mL in 1 JUG; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2020

Labeler - BuckAirways Inc. (117488255)

Registrant - Berdor Health (117488255)

Establishment
Name	Address	ID/FEI	Business Operations
BuckAirways Inc.		117488255	manufacture(75396-315)