SPL v1
SPL
SPL Set ID 290f5411-fda2-6521-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Polyethylene Terephthalate (intrinsic Viscosity 0.70-1.00) Glycerin Propylene Glycol Carbomer Interpolymer Type A (55000 Cps) Trolamine D&c Red No. 33 Methacrylic Acid - Ethyl Acrylate Copolymer (4500 Mpa.s) Diatomaceous Earth

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-11
Description

Active ingredient: Ethyl alcohol, 62%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

FLAMMBLE. Keep away from fire or flame.

Indications and Usage

Uses:

  • Hand sanitizer to help reduce bacteria on the skin.
  • Recommended for repeated use.
Dosage and Administration

Directions:

  • Apply a small amount into palm of hand
  • Rub thoroughly over both hands until dry
  • Not to be rinsed off with water
  • Children must be supervised when using this product
  • For personal / domestic use
  • Do not dilute product
Description

Active ingredient: Ethyl alcohol, 62%

Section 44425-7

Other Information:

Do not store in temperatures above 118 F

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness persists for more than 72 hours.

Section 50567-7

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

Section 51727-6

Inactive ingredients: water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, acrylates copolymer, polyethylene terephthalate, red 33, diatomaceous earth.

Section 51945-4

Section 55105-1

Purpose Antiseptic

Section 55106-9

Active ingredient:

Ethyl alcohol, 62%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Hand sanitizer to help reduce bacteria on the skin.
  • Recommended for repeated use.
Dosage and Administration (34068-7)

Directions:

  • Apply a small amount into palm of hand
  • Rub thoroughly over both hands until dry
  • Not to be rinsed off with water
  • Children must be supervised when using this product
  • For personal / domestic use
  • Do not dilute product
Warnings and Precautions (34071-1)

Warnings:

For external use only.

FLAMMBLE. Keep away from fire or flame.

Section 44425-7 (44425-7)

Other Information:

Do not store in temperatures above 118 F

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

Section 51727-6 (51727-6)

Inactive ingredients: water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, acrylates copolymer, polyethylene terephthalate, red 33, diatomaceous earth.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Antiseptic

Section 55106-9 (55106-9)

Active ingredient:

Ethyl alcohol, 62%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:04.340968 · Updated: 2026-03-14T22:54:16.821321