SPL v4
SPL
SPL Set ID 3ce56a5e-6ced-4ec4-ab84-bcba2e7ceebc
Route
TOPICAL
Published
Effective Date 2020-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 L)
Inactive Ingredients
Aloe Vera Leaf Glycerin Hydroxypropyl Cellulose, Unspecified .alpha.-tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-04

Description

Ethyl Alcohol 70%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Ethyl Alcohol 70%

Use

For rinse-free hand sanitizing to remove 99.9% bacteria on skin.

Section 51945-4

4 ounces (118 mL) - NDC 00000-000-00

8 ounces (236 mL) - NDC 00000-000-00

16 ounces (437 mL) - NDC 00000-000-00

Warnings

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

Store under 105°F

Active Ingredients

Ethyl Alcohol 70%

Inactive Ingredients

Aloe Barbadenisis Leaf, Glycerin, Hydroxypropylcellulose, Vitamin E, Water

When Using This Product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop Use and Ask A Doctor If

irritation and redness develop and persist.

Keep Out of Reach of Children.

If swallowed, get medical health promptly


Structured Label Content

Use

For rinse-free hand sanitizing to remove 99.9% bacteria on skin.

Section 51945-4 (51945-4)

4 ounces (118 mL) - NDC 00000-000-00

8 ounces (236 mL) - NDC 00000-000-00

16 ounces (437 mL) - NDC 00000-000-00

Purpose

Antibacterial

Warnings

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

Store under 105°F

Active Ingredients

Ethyl Alcohol 70%

Inactive Ingredients

Aloe Barbadenisis Leaf, Glycerin, Hydroxypropylcellulose, Vitamin E, Water

When Using This Product (When using this product)

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation and redness develop and persist.

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

If swallowed, get medical health promptly


Advanced Ingredient Data


Raw Label Data

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