80% ALCOHOL GEL- alcohol solution

80% Alcohol Gel by

Drug Labeling and Warnings

80% Alcohol Gel by is a Otc medication manufactured, distributed, or labeled by Phoenix Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Rub

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin 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 if 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, glycerin USP, hydrogen peroxide, carbomer, TEA.

Package Label - Principal Display Panel

[Divina 16 fl oz]

NDC: 73956-294-16

MADE IN USA
Divina Professional Products
Terryville, CT 06786
www.divinaproducts.com

HAND
SANITIZER
Alcohol Antiseptic 80%
Topical Solution
Antiseptic Hand Rub
Non-Sterile Solution
16 fl oz. | 473 mL

Since 1969 Divina has been
manufacturing premium quality
salon-use solutions that professionals
rely on every day to provide
superior results and happy clients.
Product integrity and value are the
cornerstones of our business.

Professional Salon Solutions

OVER 50 YEARS

Members of the
Professional Beauty Association

DIRECTIONS FOR USE:
1. If possible, first thoroughly wash hands with
soap and water for at least 20 seconds.
2. Apply enough of the product to the palm of your
hand to wet your hands completely.
3. Rub your hands and fingers together to
completely cover all areas until dry.
Keep away from EYES or any mucous membranes.

INSTRUCCIONES DE USO:
1. Si es posible, primero lávese bien las manos
con agua y jabón durante al menos 20 segundos.
2. Aplique suficiente producto en la palma de su
mano para humedecerlas por completo.
3. Frote sus manos y dedos para cubrir
completamente todas las áreas hasta que estén
secas.
Mantener alejado de los OJOS o de las
membranas mucosas.

6 7667425002 9

025-094012D12 998-DI9712G01 Rev 0420

Package Label - Principal Display Panel

[Divina 32 fl oz]

NDC: 73956-294-32

MADE IN USA
Divina Professional Products
Terryville, CT 06786
www.divinaproducts.com

HAND
SANITIZER
Alcohol Antiseptic 80%
Topical Solution
Antiseptic Hand Rub
Non-Sterile Solution
32 fl oz. | 946 mL

Since 1969 Divina has been
manufacturing premium quality
salon-use solutions that professionals
rely on every day to provide
superior results and happy clients.
Product integrity and value are the
cornerstones of our business.

Professional Salon Solutions

OVER 50 YEARS

Members of the
Professional Beauty Association

DIRECTIONS FOR USE:
1. If possible, first thoroughly wash hands with
soap and water for at least 20 seconds.
2. Apply enough of the product to the palm of your
hand to wet your hands completely.
3. Rub your hands and fingers together to
completely cover all areas until dry.
Keep away from EYES or any mucous membranes.

INSTRUCCIONES DE USO:
1. Si es posible, primero lávese bien las manos
con agua y jabón durante al menos 20 segundos.
2. Aplique suficiente producto en la palma de su
mano para humedecerlas por completo.
3. Frote sus manos y dedos para cubrir
completamente todas las áreas hasta que estén
secas.
Mantener alejado de los OJOS o de las
membranas mucosas.

6 7667425003 6

025-094013D06 998-DI9713G01 Rev 0420

Package Label - Principal Display Panel

[Phoenix Gallon]

NDC: 73956-194-28

6 7667401005 0

Phoenix Problem Solving Products

HAND

SANITIZER
Alcohol Antiseptic 80%
Topical Solution
Antiseptic Hand Rub - Non-Sterile Solution
3.79 Liters (1 Gallon)

DIRECTIONS FOR USE:
1. If possible, first thoroughly wash hands with
soap and water for at least 20 seconds.
2. Apply enough of the product to the palm of your
hand to wet your hands completely.
3. Rub your hands and fingers together to
completely cover all areas until dry.
Keep away from EYES or any mucous membranes.

INSTRUCCIONES DE USO:
1. Si es posible, primero lávese bien las manos
con agua y jabón durante al menos 20 segundos.
2. Aplique suficiente producto en la palma de su
mano para humedecerlas por completo.
3. Frote sus manos y dedos para cubrir
completamente todas las áreas hasta que estén
secas.
Mantener alejado de los OJOS o de las
membranas mucosas.

Distributed by:

Phoenix Products Company

55 Container Drive, Terryville, CT 06786

Rev. No 0320

Item # 001-094015P04

998-PHHS15G01

Phoenix is a registered trademark

of Phoenix Products Company.

www.phoenixproductsco.com

INGREDIENTS AND APPEARANCE

80% ALCOHOL GEL 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73956-294
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	.5 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	18.35 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	.5 mL  in 100 mL
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)	.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73956-294-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 73956-294-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 73956-294-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

80% ALCOHOL GEL 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73956-194
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	.5 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	17.6 mL  in 100 mL
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)	.3 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73956-194-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 73956-194-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 73956-194-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 73956-194-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - Phoenix Products Company (101332237)

Establishment
Name	Address	ID/FEI	Business Operations
Phoenix Products Company		101332237	manufacture(73956-194, 73956-294)