afe98bdb-3ae4-d0c4-e053-2995a90a610c

SPL v1
SPL
SPL Set ID afe98bdb-3ae4-d0c4-e053-2995a90a610c
Route
topical
Published
Effective Date 2020-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
water carbomer homopolymer, unspecified type triclosan trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-09-17
Purpose

Antiseptic

Description

Alcohol 75% v/v

Medication Information

Warnings

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

Purpose

Antiseptic

Directions
  • Place enough product 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.
Other Information
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Description

Alcohol 75% v/v

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Section 51945-4

​NDC 61696-001-01 (59.2 mL)

NDC 61696-001-02 (500 mL)

Do Not Use

Do not use

  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 75% v/v

Inactive Ingredients:

Water, Carbomer, Triclosan, Triethanolamine, Fragrance.

When Using This Product

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

Stop Use and Ask A Doctor

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

Keep Out of Reach of Children.

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

Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions
  • Place enough product 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.
Other Information
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Section 51945-4 (51945-4)

​NDC 61696-001-01 (59.2 mL)

NDC 61696-001-02 (500 mL)

Do Not Use (Do not use)

Do not use

  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient (Active ingredient)

Alcohol 75% v/v

Inactive Ingredients:

Water, Carbomer, Triclosan, Triethanolamine, Fragrance.

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

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

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:48.151001 · Updated: 2026-03-14T22:58:34.022816