SPL v2
SPL
SPL Set ID b3dd272e-5f0d-5578-e053-2a95a90ad764
Route
TOPICAL
Published
Effective Date 2020-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Caprylyl Glycol Glycerin Water Aminomethylpropanol Fd&c Yellow No. 5 Fragrance Clean Orc0600327 Carbomer 940 Fd&c Blue No. 1 Aluminum Lake Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-16
Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin that can cause disease. recommended for repeat use

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

Do not use in or near the eyes. in case of contact, rinse thorougly with water.

Warnings

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

Directions
  • Place enough product in your palm to thorougly cover your hands. Rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store below 110FC (43C)
  • May discolor certain fabrics or surfaces.
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, Carprylyl Glycol, Aloe Vera, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Yellow 5 and Blue 1.

Package Label Principal Display Panel

3.78 L NDC: 78257-919-01

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin that can cause disease. recommended for repeat use

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)

Do not use in or near the eyes. in case of contact, rinse thorougly with water.

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • Place enough product in your palm to thorougly cover your hands. Rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store below 110FC (43C)
  • May discolor certain fabrics or surfaces.
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water, Carprylyl Glycol, Aloe Vera, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Yellow 5 and Blue 1.

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

3.78 L NDC: 78257-919-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:04.286864 · Updated: 2026-03-14T22:58:53.700990