Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d0081c50-c0d2-436a-ba83-5d1982ae64b7
Route
TOPICAL
Published
Effective Date 2015-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (56 mg)
Inactive Ingredients
Edetate Disodium Propanediol Polysorbate 20 Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-08-17

Description

Ethyl Alcohol 63.00%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 63.00%

Uses

For handwashing to decrease bacteria on the skin that may cause disease. Recommended for repeat use.

Warnings

For external use only: Hands. Flammable. Keep away from flame.

When using this product: keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor: if irritation develops.

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Active Ingredient

Ethyl Alcohol 63.00%

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Blue 1, Dimethicone, Disodium EDTA, DMDM Hydantoin, Fragrance, Polysorbarte, Propanediol, Tocopherol (Vitamin E), Water, Yellow 5.

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Uses

For handwashing to decrease bacteria on the skin that may cause disease. Recommended for repeat use.

Purpose

Antiseptic

Warnings

For external use only: Hands. Flammable. Keep away from flame.

When using this product: keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor: if irritation develops.

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Active Ingredient (Active ingredient)

Ethyl Alcohol 63.00%

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Blue 1, Dimethicone, Disodium EDTA, DMDM Hydantoin, Fragrance, Polysorbarte, Propanediol, Tocopherol (Vitamin E), Water, Yellow 5.

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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