Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID c9247977-4c47-457b-9d20-f991c71d25c3
Route
TOPICAL
Published
Effective Date 2020-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Edetate Disodium Glycerin Carbomer 934 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-28

Description

Ethyl Alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Dosage and Administration

No water as needed. Apply a small amount of product to dry skin.

Description

Ethyl Alcohol 62%

Uses

Hand sanitizer to help decrease virus on the skin. When water, soap and towel are not available. Recommended for repeated use.

Warnings

For external use only.

Avoid contact with the wound. 

Do not allow this produts to come into contact with eyes or nearby. If you accidentally touch a wound or eye, rinse immediately

with water. If skin irritation or sensitivity occurs, discontinue use immediately and consult your doctor.

Not recommended for infants. 

Product Labeling

Active Ingredient

Ethyl Alcohol 62%

Inactive Ingredients

Triethanolamine, Carbomer, Glycerine, Disodium EDTA, Pure Water

When Using This Product

Dn not allow children under 6 years of age to handle or apply, contact your doctor immediately.

Keep Out of Reach of Children.

If swalllowed carelessly, contact your doctor immdiately.


Structured Label Content

Uses

Hand sanitizer to help decrease virus on the skin. When water, soap and towel are not available. Recommended for repeated use.

Dosage and Administration (34068-7)

No water as needed. Apply a small amount of product to dry skin.

Purpose

Antiseptic

Warnings

For external use only.

Avoid contact with the wound. 

Do not allow this produts to come into contact with eyes or nearby. If you accidentally touch a wound or eye, rinse immediately

with water. If skin irritation or sensitivity occurs, discontinue use immediately and consult your doctor.

Not recommended for infants. 

Product Labeling

Active Ingredient

Ethyl Alcohol 62%

Inactive Ingredients

Triethanolamine, Carbomer, Glycerine, Disodium EDTA, Pure Water

When Using This Product (When using this product)

Dn not allow children under 6 years of age to handle or apply, contact your doctor immediately.

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

If swalllowed carelessly, contact your doctor immdiately.


Advanced Ingredient Data


Raw Label Data

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