SPL v2
SPL
SPL Set ID a4bf1b86-3da6-9821-e053-2995a90aaaae
Route
TOPICAL
Published
Effective Date 2020-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Water Trolamine Levomenthol Hyaluronate Sodium 1,2-hexanediol Aloe Vera Leaf

Identifiers & Packaging

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

Ethyl alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 70% v/v. Purpose: Antiseptic

Uses

Hand Sanitizer to help reduce bacteria on the skin.

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 appears and lasts.

Section 50567-7

When using this product do not use in or near the eye. In case of contact with eyes, rinse thorougly with water.

Warnings

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

Directions
  • Place enough product on palm to cover all surfaces and rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surfaces
Active Ingredient(s)

Ethyl alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, Glycerin, Carbomer, Trolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Package Label Principal Display Panel

500 mL NDC: 76890-101-01

Structured Label Content

Uses

Hand Sanitizer to help reduce bacteria on the skin.

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 appears and lasts.

Section 50567-7 (50567-7)

When using this product do not use in or near the eye. In case of contact with eyes, rinse thorougly with water.

Purpose

Antiseptic

Warnings

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

Directions
  • Place enough product on palm to cover all surfaces and rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surfaces
Active Ingredient(s)

Ethyl alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Trolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

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

500 mL NDC: 76890-101-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:42.602509 · Updated: 2026-03-14T22:56:56.523889