b3dd272e-5f0d-5578-e053-2a95a90ad764

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
Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.
Other Information
  • Store below 110FC (43C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients

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

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.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

3.78 L NDC: 78257-919-01

Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.
Other Information (Other information)
  • Store below 110FC (43C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

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

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.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

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