SPL v1
SPL
SPL Set ID a359d3c8-59e7-5565-e053-2a95a90a3bad
Route
TOPICAL
Published
Effective Date 2020-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 mL)
Inactive Ingredients
Aloe Vera Leaf Carbomer 940 Water Dimethicone 100 Fenoprop Triisopropanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-16
Description

This hand sanitizer is manufactured using the following ingredients: Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Aloe Barbadensis Leaf Carbomer Dimethicone Triisopropanolamine Water

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This hand sanitizer is manufactured using the following ingredients: Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Aloe Barbadensis Leaf Carbomer Dimethicone Triisopropanolamine Water

Use

For handwashing to decrease bacteria on the skin.

Section 42229-5

This hand sanitizer is manufactured using the following ingredients:

  • Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Aloe Barbadensis Leaf
  • Carbomer
  • Dimethicone
  • Triisopropanolamine
  • Water
Section 50565-1

Keep out of reach of children. If swallowed, get medical help promptly.

Section 50566-9

Stop use and ask a doctor if irritation or redness develop and persist.

Section 50567-7

Do not use in eyes. In case of contact with eyes, rinse with water.

Section 51945-4

3785ml NDC: 75498-070-01

Warnings

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information
  • Store under 105F
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water

Package Label Principal Display Panel

237ml NDC: 75498-070-08

Structured Label Content

Use

For handwashing to decrease bacteria on the skin.

Section 42229-5 (42229-5)

This hand sanitizer is manufactured using the following ingredients:

  • Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Aloe Barbadensis Leaf
  • Carbomer
  • Dimethicone
  • Triisopropanolamine
  • Water
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help promptly.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develop and persist.

Section 50567-7 (50567-7)

Do not use in eyes. In case of contact with eyes, rinse with water.

Section 51945-4 (51945-4)

3785ml NDC: 75498-070-01

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information (Other information)
  • Store under 105F
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water

Package Label Principal Display Panel (Package Label - Principal Display Panel)

237ml NDC: 75498-070-08

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:14.376531 · Updated: 2026-03-14T22:56:14.192854