germ shark px4 hand sanitizer

germ shark px4 hand sanitizer
SPL v2
SPL
SPL Set ID b73b4c80-a04d-4a17-b679-3afaead43bf1
Route
topical
Published
Effective Date 2020-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.8 mL)
Inactive Ingredients
water glycerin hydrogen peroxide

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-03

Purpose

Antiseptic

Description

Alcohol 80% v/v


Medication Information

Warnings

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

Purpose

Antiseptic

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
  • Avoid freezing and excessive heat above 40C (104F)
  • Store between 15-30C (59-86F)
Inactive Ingredients

Purified water USP 18.425%, Glycerin (glycerol) 1.45%, Hydrogen peroxide 0.125%

Description

Alcohol 80% v/v

Use(s)

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

Do Not Use
  • on children less than 2 months of age- supervise use by children
  • on open skin wounds
  • do NOT drink - not for internal consumption
Drug Facts

Package Labeling:

Active Ingredient(s)

Alcohol 80% v/v

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

if 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.


Structured Label Content

Warnings

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

Purpose

Antiseptic

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
  • Avoid freezing and excessive heat above 40C (104F)
  • Store between 15-30C (59-86F)
Inactive Ingredients

Purified water USP 18.425%, Glycerin (glycerol) 1.45%, Hydrogen peroxide 0.125%

Use(s)

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

Do Not Use
  • on children less than 2 months of age- supervise use by children
  • on open skin wounds
  • do NOT drink - not for internal consumption
Drug Facts

Package Labeling:

Active Ingredient(s)

Alcohol 80% v/v

When Using This Product (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 (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.


Advanced Ingredient Data


Raw Label Data

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