Ndc- 63148-526

Ndc- 63148-526
SPL v2
SPL
SPL Set ID c4c2b38b-57f7-4854-a4ec-db90645094cb
Route
TOPICAL
Published
Effective Date 2020-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (800 mg)
Inactive Ingredients
Water Polyethylene Glycol 300 Isopropyl Alcohol Glycerin Isopropyl Myristate Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl- Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-02
Description

Ethyl Alcohol (80%)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol (80%)

Uses

For Personal hand hygiene to help 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
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry
  • Children under 6 years should be supervised when using this product
Do Not Use
  • on children less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin
2oz Sanitizer

8oz Sanitizer

15oz Sanitizer

32oz Sanitizer

40oz Sanitizer

64oz Sanitizer

128oz Sanitizer

Other Information
  • Store at a temperature below 110 0F (43 0C)
  • May discolor certain fabrics or surfaces
Active Ingredients

Ethyl Alcohol (80%)

Inactive Ingredients

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

Questions Or Comments ?

1-866-695-3030

When Using This Product

Avoid contact with eyes. If contact occurs, rinse 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 Centre immediately

Structured Label Content

Uses

For Personal hand hygiene to help 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
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry
  • Children under 6 years should be supervised when using this product
Do Not Use (Do not use)
  • on children less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin
2oz Sanitizer

8oz Sanitizer

15oz Sanitizer

32oz Sanitizer

40oz Sanitizer

64oz Sanitizer

128oz Sanitizer

Other Information
  • Store at a temperature below 110 0F (43 0C)
  • May discolor certain fabrics or surfaces
Active Ingredients

Ethyl Alcohol (80%)

Inactive Ingredients

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

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 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 Centre immediately

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:13.571520 · Updated: 2026-03-14T23:06:42.095401