af72971f-b386-6998-e053-2995a90a9f07

SPL v1
SPL
SPL Set ID af72971f-b386-6998-e053-2995a90a9f07
Route
topical
Published
Effective Date 2020-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.000411 g)
Inactive Ingredients
denatonium benzoate glycerin hydrogen peroxide water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-10-01

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 80% v/v. Purpose: Antiseptic


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame. Do not consume.

Purpose

Antiseptic, Hand Sanitizer

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 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor fabrics.
Inactive Ingredients

denatonium benzoate, glycerin, hydrogen peroxide, orange flavor, purified water USP

Description

Alcohol 80% v/v. Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

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 occurs. These may be signs of a serious condition.

Section 50567-7

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 if irritation or rash occurs. These may be signs of a serious condition.



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

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

Alcohol 80% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

100 mL

NDC: 80252-100-01

3785 mL or 3.785L or 1 Gallon

NDC: 80252-100-02

250mL

NDC: 80252-100-03


Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame. Do not consume.

Purpose

Antiseptic, Hand Sanitizer

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 (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor fabrics.
Inactive Ingredients (Inactive ingredients)

denatonium benzoate, glycerin, hydrogen peroxide, orange flavor, purified water USP

Use

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

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 occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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 if irritation or rash occurs. These may be signs of a serious condition.



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

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

Alcohol 80% v/v. Purpose: Antiseptic

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

100 mL

NDC: 80252-100-01

3785 mL or 3.785L or 1 Gallon

NDC: 80252-100-02

250mL

NDC: 80252-100-03


Advanced Ingredient Data


Raw Label Data

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