Hand Sanitizer

Hand Sanitizer
SPL v1
SPL
SPL Set ID adf47e6a-3c2e-3e0b-e053-2a95a90a3122
Route
TOPICAL
Published
Effective Date 2020-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1.5 mL)
Inactive Ingredients
Glycerin Denatonium Benzoate Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-09
Description

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Dosage and Administration

Topical Liquid applied to outer surface of the body, specifcially hands.

Description

Ethyl Alcohol 80% v/v

Use

Hand Sanitzer to help reduce bacteria on the skin that could cause disease or illness.

Label

Liquid Application 1 Gallon (3.76L) NDC: 43636-007-28

Warnings
  • For external use only.
  • Flammable. Keep away from fire or flame.
Directions
  • Apply to palm of your hands as needed. Rub hands together to spread gel until dry.
  • No rinsing or towel required.
  • Children under 6 years of age consult physician before use and supervise when using this product.
Active Ingredient

Ethyl Alcohol 80% v/v

Other Information
  • Avoid freezing and store below 105°F (41°C).
  • May discolor or harm fabrics, wood finishes & plastics.
Inactive Ingredients
  • Water
  • Glycerin
  • Hydrogen Peroxide
  • Biterex
  • Fragrance
When Using This Product
  • keep out of eyes, ears, and mouth. In case of contact, flush thoroughly with water.
  • Avoid contact with open wounds.
  • Do not ingest or inhale.
Stop Us and Ask A Doctor

if irritation or rash appears and persists more than 72 hours.

Keep Out of the Reach of Children.

If swallowed, get medical help or contact the Poison Control Center right away.

Structured Label Content

Use (USE)

Hand Sanitzer to help reduce bacteria on the skin that could cause disease or illness.

Label

Liquid Application 1 Gallon (3.76L) NDC: 43636-007-28

Dosage and Administration (34068-7)

Topical Liquid applied to outer surface of the body, specifcially hands.

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)
  • For external use only.
  • Flammable. Keep away from fire or flame.
Directions (DIRECTIONS)
  • Apply to palm of your hands as needed. Rub hands together to spread gel until dry.
  • No rinsing or towel required.
  • Children under 6 years of age consult physician before use and supervise when using this product.
Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 80% v/v

Other Information (OTHER INFORMATION)
  • Avoid freezing and store below 105°F (41°C).
  • May discolor or harm fabrics, wood finishes & plastics.
Inactive Ingredients (INACTIVE INGREDIENTS)
  • Water
  • Glycerin
  • Hydrogen Peroxide
  • Biterex
  • Fragrance
When Using This Product (When using this product)
  • keep out of eyes, ears, and mouth. In case of contact, flush thoroughly with water.
  • Avoid contact with open wounds.
  • Do not ingest or inhale.
Stop Us and Ask A Doctor (Stop us and ask a doctor)

if irritation or rash appears and persists more than 72 hours.

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

If swallowed, get medical help or contact the Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:53.796505 · Updated: 2026-03-14T22:58:42.480630