Ndc- 63148-660

Ndc- 63148-660
SPL v2
SPL
SPL Set ID 3752d034-d4b4-47ab-b1bb-066cef7fde75
Route
TOPICAL
Published
Effective Date 2021-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 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%) Ethylene Brassylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-02
Description

Ethyl Alcohol (70%)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol (70%)

Uses

For Personal hand hygiene to help the spread of bacteria. 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
24 Oz Sanitizer

50 Oz Sanitizer

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

Ethyl Alcohol (70%)

Inactive Ingredients

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

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 Centre immediately

Structured Label Content

Uses

For Personal hand hygiene to help the spread of bacteria. 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
24 Oz Sanitizer (24 oz sanitizer)

50 Oz Sanitizer (50 oz sanitizer)

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

Ethyl Alcohol (70%)

Inactive Ingredients

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

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 Centre immediately

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:12.851486 · Updated: 2026-03-14T23:06:42.095401