SPL v1
SPL
SPL Set ID bbf7c26f-e715-4b5c-8654-5663744a32b9
Route
TOPICAL
Published
Effective Date 2020-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Propylene Glycol Water Carbomer 934 Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-04
Description

NA

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

NA

Use

Hand sanitizer to help decrease bacteria that potentially can cause disease

For use when soap and water is not available

Section 42229-5

NA

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 51945-4

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Place enough product on the skin to cover all surface
  • Rub hands together untill dry
  • Supervise children under 6 years of age whenusing this product to avoid swallowing
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 75% v/v

Inactive Ingredients

Water, propylene glycol, glycerin, carbomer, triethanolamine

Structured Label Content

Use

Hand sanitizer to help decrease bacteria that potentially can cause disease

For use when soap and water is not available

Section 42229-5 (42229-5)

NA

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 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Place enough product on the skin to cover all surface
  • Rub hands together untill dry
  • Supervise children under 6 years of age whenusing this product to avoid swallowing
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, propylene glycol, glycerin, carbomer, triethanolamine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:26.386304 · Updated: 2026-03-14T22:56:37.078705