GEL HAND SANITIZER- moisturizing gel hand sanitizer gel 
BuckAirways Inc.

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.

----------

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

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. 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

Front 2 oz

BACK

Back 2 oz

118ML NDC Code 75396-315-18

FRONT

Front 4 oz

BACK

Back 4 oz

3785ML NDC Code 75396-315-19

FRONT

Front 128 oz

BACK

Back 128 oz

GEL HAND SANITIZER 
moisturizing gel hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75396-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75396-315-17118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/25/2020
2NDC:75396-315-1859 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/25/2020
3NDC:75396-315-193785 mL in 1 JUG; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2020
Labeler - BuckAirways Inc. (117488255)
Registrant - Berdor Health (117488255)
Establishment
NameAddressID/FEIBusiness Operations
BuckAirways Inc.117488255manufacture(75396-315)

Revised: 5/2020
Document Id: a4eec32a-2d9a-34f4-e053-2995a90a3d3c
Set id: a4eec32a-2d99-34f4-e053-2995a90a3d3c
Version: 1
Effective Time: 20200505
 
BuckAirways Inc.