Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID dbfdecf0-a961-4cc5-bf87-ae30bbc302dd
Route
TOPICAL
Published
Effective Date 2024-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Glycerin Water Trolamine Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-31

Description

Alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 62%

Uses

Hand sanitizer to help reduce bacterial that potentially can cause disease.

For use when soap and water are not available

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 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 iritation or rash occurs. These may be signs of a serious confition.

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.

Product Labeling

Active Ingredient

Alcohol 62%

Inactive Ingredients

Pure water, Glycerine, Carbomer,  Triethanolamine, Disodium EDTA

Keep Out of Reach of Children.

If swallowed get medical help or contact a Posion Control Center immediately.


Structured Label Content

Uses

Hand sanitizer to help reduce bacterial that potentially can cause disease.

For use when soap and water are not available

Purpose

Antiseptic

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 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 iritation or rash occurs. These may be signs of a serious confition.

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.

Product Labeling

Active Ingredient

Alcohol 62%

Inactive Ingredients

Pure water, Glycerine, Carbomer,  Triethanolamine, Disodium EDTA

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

If swallowed get medical help or contact a Posion Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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