Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c516983f-ebc1-fcd4-e053-2a95a90a72c8
Route
TOPICAL
Published
Effective Date 2020-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.7 mL)
Inactive Ingredients
Aminomethylpropanol Carbomer 940 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-16

Description

Ethyl alcohol 70% v/v

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl alcohol 70% v/v

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

Directions
  • Place enough product in your palm to thoroughly cover hands and rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product
Active Ingredient

Ethyl alcohol 70% v/v

Other Information
  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces
Inactive Ingredients

water (aqua), carbomer, fragrance, propanediol 2-amino methyl-1 propanol solution

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 Out of Reach of Children.

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

Package/label Principal Display Panel

DR. DEAN

70% Ethyl Alcohol

GEL HAND SANITIZER

MADE IN THE USA

FOR EXTERNAL USE ONLY

4 fl oz (118 mL)

NDC 81657-004-01

Drug Facts

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamdsupply.com

Store below 110°F (43°C)

May discolor certain fabrics or surfaces

DR. DEAN

70% Ethyl Alcohol

GEL HAND SANITIZER

MADE IN THE USA

FOR EXTERNAL USE ONLY

8 fl oz (236 mL)

NDC 81657-004-02

Drug Facts

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamdsupply.com

Store below 110°F (43°C)

May discolor certain fabrics or surfaces

DR. DEAN

70% Ethyl Alcohol

GEL HAND SANITIZER

MADE IN THE USA

FOR EXTERNAL USE ONLY

128 fl oz (3785 mL)

NDC 81657-004-03

Drug Facts

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamdsupply.com

Store below 110°F (43°C)

May discolor certain fabrics or surfaces


Structured Label Content

Use

Hand sanitizer to help reduce bacteria on the skin

Purpose

Antimicrobial

Warnings

Flammable. Keep away from fire or flame.

For external use only

Directions
  • Place enough product in your palm to thoroughly cover hands and rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product
Active Ingredient (Active ingredient)

Ethyl alcohol 70% v/v

Other Information (Other information)
  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

water (aqua), carbomer, fragrance, propanediol 2-amino methyl-1 propanol solution

When Using This Product (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 (Stop use and ask a doctor if)

irritation or rash appears and lasts

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

DR. DEAN

70% Ethyl Alcohol

GEL HAND SANITIZER

MADE IN THE USA

FOR EXTERNAL USE ONLY

4 fl oz (118 mL)

NDC 81657-004-01

Drug Facts

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamdsupply.com

Store below 110°F (43°C)

May discolor certain fabrics or surfaces

DR. DEAN

70% Ethyl Alcohol

GEL HAND SANITIZER

MADE IN THE USA

FOR EXTERNAL USE ONLY

8 fl oz (236 mL)

NDC 81657-004-02

Drug Facts

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamdsupply.com

Store below 110°F (43°C)

May discolor certain fabrics or surfaces

DR. DEAN

70% Ethyl Alcohol

GEL HAND SANITIZER

MADE IN THE USA

FOR EXTERNAL USE ONLY

128 fl oz (3785 mL)

NDC 81657-004-03

Drug Facts

Distributed by USA Medical Supply

Northbrook, IL 60062

www.usamdsupply.com

Store below 110°F (43°C)

May discolor certain fabrics or surfaces


Advanced Ingredient Data


Raw Label Data

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