SPL v1
SPL
SPL Set ID 3abd4d79-3dd0-682a-e063-6294a90a28ef
Route
TOPICAL
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (71 mL)
Inactive Ingredients
Leuconostoc/radish Root Ferment Filtrate Phenoxyethanol Fd&c Yellow No. 5 Fd&c Blue No. 1 Butylene Glycol Aloe Barbadensis Leaf Juice Water Glycereth-26 Dipropylene Glycol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-25

Description

ETHYL ALCOHOL 70%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 70%

Use

To decrease bacteria on the skin that could cause disease.

When water, soap and towel are not available.

Recommended for repeated use.

Section 51945-4

Section 55106-9

ETHYL ALCOHOL 70%

Warnings

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

Directions

Spray product in your palm and rub hands together until dry.

For children under 6, use only under adult supervision.

Not recommended for infants.

Others Information

Do not store above 105°F.

May discolor some fabrics.

Harmful to wood finishes and plastics.

Inactive Ingredients

Water, Glycerin, Dipropylene Glycol, Glycereth-26, Fragrance, Butylene Glycol, Leuconostoc/Radish Root Ferment Filtrate, Aloe Barbadensis Leaf Juice, Phenoxyethanol. May Contain: Red 40 Lake (Cl 16035), Red 33 Lake (CI 17200), Red 4 Lake (CI 14700), Yellow 5 Lake (CI 19140:1), Blue 1 Lake (CI 42090:2)

When Using This Product:

Keep out of eyes, ears, or mouth.

In case of eye contact, flush eyes thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest.

Stop Use and Ask A Doctor If

Redness of irritation develop.

Condition persists for more than 72 hours.

Keep Out of Reach of Children

Children should be supervised by an adult when using this product.

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


Structured Label Content

Use

To decrease bacteria on the skin that could cause disease.

When water, soap and towel are not available.

Recommended for repeated use.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

ETHYL ALCOHOL 70%

Purpose

ANTISEPTIC

Warnings

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

Directions

Spray product in your palm and rub hands together until dry.

For children under 6, use only under adult supervision.

Not recommended for infants.

Others Information (Others information)

Do not store above 105°F.

May discolor some fabrics.

Harmful to wood finishes and plastics.

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Dipropylene Glycol, Glycereth-26, Fragrance, Butylene Glycol, Leuconostoc/Radish Root Ferment Filtrate, Aloe Barbadensis Leaf Juice, Phenoxyethanol. May Contain: Red 40 Lake (Cl 16035), Red 33 Lake (CI 17200), Red 4 Lake (CI 14700), Yellow 5 Lake (CI 19140:1), Blue 1 Lake (CI 42090:2)

When Using This Product: (When using this product:)

Keep out of eyes, ears, or mouth.

In case of eye contact, flush eyes thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest.

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

Redness of irritation develop.

Condition persists for more than 72 hours.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Children should be supervised by an adult when using this product.

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


Advanced Ingredient Data


Raw Label Data

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