Defendx Hand Sanitizer Gel

Defendx Hand Sanitizer Gel
SPL v3
SPL
SPL Set ID a6ba0852-19f3-0ae4-e053-2995a90aea95
Route
TOPICAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Water Trolamine .alpha.-tocopherol Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-28

Description

Alcohol 70% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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



Warnings

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

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.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 70% v/v.

Inactive Ingredients

Carbomer, Glycerin, Triethanolamine, Vitamin E, Water

Product Label (principal Display Panel)



Distributed by:

DefendX

99 Wall Street #570

New York, NY 10005

United States of America

www.defendxonline.com

DefendX Hand Sanitizer (2 fl oz) NDC: 78256-003-02

DefendX Hand Sanitizer (8 fl oz) NDC: 78256-003-08

DefendX Hand Sanitizer (16 fl oz) NDC: 78256-003-16

DefendX Hand Sanitizer (32 fl oz) NDC: 78256-003-32

DefendX Hand Sanitizer (64 fl oz) NDC: 78256-003-64

DefendX Hand Sanitizer (1 Gal) NDC: 78256-003-01


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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



Purpose

Antiseptic

Warnings

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

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.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

Carbomer, Glycerin, Triethanolamine, Vitamin E, Water

Product Label (principal Display Panel) (Product Label (Principal Display Panel))



Distributed by:

DefendX

99 Wall Street #570

New York, NY 10005

United States of America

www.defendxonline.com

DefendX Hand Sanitizer (2 fl oz) NDC: 78256-003-02

DefendX Hand Sanitizer (8 fl oz) NDC: 78256-003-08

DefendX Hand Sanitizer (16 fl oz) NDC: 78256-003-16

DefendX Hand Sanitizer (32 fl oz) NDC: 78256-003-32

DefendX Hand Sanitizer (64 fl oz) NDC: 78256-003-64

DefendX Hand Sanitizer (1 Gal) NDC: 78256-003-01


Advanced Ingredient Data


Raw Label Data

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