Ndc-63148-516

Ndc-63148-516
SPL v3
SPL
SPL Set ID b25bbf28-f08d-4de2-9be7-bfb6b134b49a
Route
TOPICAL
Published
Effective Date 2025-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Fragrance Clean Orc0600327 Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%) Water Peg-6 Isopropyl Alcohol Glycerin Isopropyl Myristate Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-11
Description

Ethyl Alcohol (65%)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol (65%)

Uses

for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

For external use only.

  • Flammable
  • Keep away from source of heat or fire.
Directions
  • Adults only
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Do Not Use
  • On infants less than 2 months of age
  • On open skin wounds.
  • On broken or damaged skin.
Active Ingredient

Ethyl Alcohol (65%)

Inactive Ingredients

Aloe Barbadensis Leaf Juice,,AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-6, Tocopheryl Acetate, Water.

Questions Or Comments?

1-866-695-3030

When Using This Product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

Stop Use and Ask A Doctor

if irritation or redness develops and lasts.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Principal Display Panel (8 Oz)

Principal Display Panel (32 Oz)

Structured Label Content

Uses

for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Purpose

Antiseptic

Warnings

For external use only.

  • Flammable
  • Keep away from source of heat or fire.
Directions
  • Adults only
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Do Not Use (Do not use)
  • On infants less than 2 months of age
  • On open skin wounds.
  • On broken or damaged skin.
Active Ingredient

Ethyl Alcohol (65%)

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice,,AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-6, Tocopheryl Acetate, Water.

Questions Or Comments? (Questions or comments?)

1-866-695-3030

When Using This Product (When using this Product)

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

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

if irritation or redness develops and lasts.

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

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Principal Display Panel (8 Oz) (Principal Display Panel (8 oz))

Principal Display Panel (32 Oz) (Principal Display Panel (32 oz))

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:16.179136 · Updated: 2026-03-14T23:10:32.676275