63148-100-hdx Hand Sanitizer Gel.

63148-100-hdx Hand Sanitizer Gel.
SPL v4
SPL
SPL Set ID df0063b2-2e30-428e-b5cf-24e566c388c2
Route
TOPICAL
Published
Effective Date 2021-03-29
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 2021-03-22
Description

Ethyl Alcohol (70%)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol (70%)

Uses

To help reduce bacteria that can potentially cause disease. For use when 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
16 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, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Glycerin, Isopropyl Alcohol, Tocopheryl Acetate, Ethylene Brassylate.

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

Structured Label Content

Uses

To help reduce bacteria that can potentially cause disease. For use when 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
16 Oz Sanitizer (16 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, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Glycerin, Isopropyl Alcohol, Tocopheryl Acetate, Ethylene Brassylate.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.245804 · Updated: 2026-03-14T23:03:04.544899