SPL v1
SPL
SPL Set ID d0b6d09c-26e0-45c7-8d37-7d42143b2e31
Route
TOPICAL
Published
Effective Date 2024-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Tocopheryl Glucoside Aminomethylpropanol Denatonium Benzoate Maltodextrin Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-14
Description

Active ingredient Alcohol, 75% v/v

Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable, keep away  from heat or flame.

Do not use

  • In children less than 2 months of age
  • On open skin wounds
  • Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition

Indications and Usage

Uses

  • Hand sanitizer to help reduce bacteria that potentially can cause disease
  • For use when soap and water are not available
Dosage and Administration

Directions 

Place enough products on hands to cover all surfaces. Rub hands together until dry

Supervise children under 6 years of age when using this product to avoid swallowing

Description

Active ingredient Alcohol, 75% v/v

Section 44425-7

Other information

Store in a cool dry area 15 to 30C (59 to 86F)

Avoid freezing and excessive heat above 40V (104F)

Section 50565-1

Keep out of reach of  children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

Inactive ingredients

Acrylates/ C10-C30 alkyl acrylate crossploymer, Aminomethyl propanol, Aloe barbadensis leaf jiuce, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene glycol, Tocopheryl acetate, Water

Section 51945-4

Section 55105-1

Purpose  Antiseptic

Section 55106-9

Active ingredient

Alcohol, 75% v/v

Structured Label Content

Indications and Usage (34067-9)

Uses

  • Hand sanitizer to help reduce bacteria that potentially can cause disease
  • For use when soap and water are not available
Dosage and Administration (34068-7)

Directions 

Place enough products on hands to cover all surfaces. Rub hands together until dry

Supervise children under 6 years of age when using this product to avoid swallowing

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable, keep away  from heat or flame.

Do not use

  • In children less than 2 months of age
  • On open skin wounds
  • Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition

Section 44425-7 (44425-7)

Other information

Store in a cool dry area 15 to 30C (59 to 86F)

Avoid freezing and excessive heat above 40V (104F)

Section 50565-1 (50565-1)

Keep out of reach of  children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Inactive ingredients

Acrylates/ C10-C30 alkyl acrylate crossploymer, Aminomethyl propanol, Aloe barbadensis leaf jiuce, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene glycol, Tocopheryl acetate, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose  Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Alcohol, 75% v/v

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:41.564344 · Updated: 2026-03-14T23:02:23.126471