43116-050

43116-050
SPL v1
SPL
SPL Set ID 448e7c82-f952-4993-e063-6394a90a942c
Route
TOPICAL
Published
Effective Date 2025-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 U)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-27

Description

Ethyl Alcohol 75%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75%

Use

Uses for sanitizing to help reduce bacteria on the skin.

Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

Warnings Flammable. Keep away from fire or flame. For external use only.

Directions

●For use apply thoroughly to hands as desired.

●Allow to dry without wiping.

●Children under 6 years of age should be supervised when using this product.

Do Not Use

Do not use if you are allergic to any of the ingredients.

When Using

When using this product, do not use in or near the eyes. If contact occurs, rinse eyes

thoroughly with water.

Active Ingredient

Ethyl Alcohol 75%

Other Information

●Store below 110F (43"C)

●May discolor certain fabrics or surfaces

●Don't put it in the car, keep away from high temperature.

Inactive Ingredients

Water(Aqua).

Principal Display Panel

Keep Oot of Reach of Children

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


Structured Label Content

Use

Uses for sanitizing to help reduce bacteria on the skin.

Purpose

Antimicrobial

Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

Warnings Flammable. Keep away from fire or flame. For external use only.

Directions

●For use apply thoroughly to hands as desired.

●Allow to dry without wiping.

●Children under 6 years of age should be supervised when using this product.

Do Not Use (Do not use)

Do not use if you are allergic to any of the ingredients.

When Using

When using this product, do not use in or near the eyes. If contact occurs, rinse eyes

thoroughly with water.

Active Ingredient

Ethyl Alcohol 75%

Other Information (Other information)

●Store below 110F (43"C)

●May discolor certain fabrics or surfaces

●Don't put it in the car, keep away from high temperature.

Inactive Ingredients (Inactive ingredients)

Water(Aqua).

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot 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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