a7eb0730-3b07-b228-e053-2a95a90aa404

SPL v1
SPL
SPL Set ID a7eb0730-3b07-b228-e053-2a95a90aa404
Route
topical
Published
Effective Date 2020-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
glycerin water west indian lemongrass oil acrylic acid/sodium acrylate copolymer (1:1; 600 mpa.s at 0.2%) trolamine lavender oil

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-12

Purpose

Antiseptic, Hand Sanitizer

Description

The hand sanitizer is manufactured using the following ingredients: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerine Trolamine Sterile distilled water or boiled cold water. Acrylic Acid/Sodium Acrylate Copolymer (1:1; 600 MPA.S at 0.2%) Lemongrass Oil


Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Wet hands with product thoroughly, allow to dry without wiping.
  • 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)
Inactive Ingredients

glycerin, trolamine, acrylic acid/sodiu, acrylate copolymer (1:1; 600 MPA.S at 0.2%), water, lemongrass oil

Description

The hand sanitizer is manufactured using the following ingredients: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerine Trolamine Sterile distilled water or boiled cold water. Acrylic Acid/Sodium Acrylate Copolymer (1:1; 600 MPA.S at 0.2%) Lemongrass Oil

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5

The hand sanitizer is manufactured using the following ingredients:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerine
  • Trolamine
  • Sterile distilled water or boiled cold water.
  • Acrylic Acid/Sodium Acrylate Copolymer (1:1; 600 MPA.S at 0.2%)
  • Lemongrass Oil

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 persists.

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 75% v/v. Purpose: Antiseptic

500 Ml Ndc: Ndc 75498 375 16

500 mL NDC: NDC 75498-375-16

Package Label Principal Display Panel

500 mL NDC: NDC 75498-275-16


Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Wet hands with product thoroughly, allow to dry without wiping.
  • 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)
Inactive Ingredients (Inactive ingredients)

glycerin, trolamine, acrylic acid/sodiu, acrylate copolymer (1:1; 600 MPA.S at 0.2%), water, lemongrass oil

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)

The hand sanitizer is manufactured using the following ingredients:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerine
  • Trolamine
  • Sterile distilled water or boiled cold water.
  • Acrylic Acid/Sodium Acrylate Copolymer (1:1; 600 MPA.S at 0.2%)
  • Lemongrass Oil

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 persists.

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 75% v/v. Purpose: Antiseptic

500 Ml Ndc: Ndc 75498 375 16 (500 mL NDC: NDC 75498-375-16)

500 mL NDC: NDC 75498-375-16

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

500 mL NDC: NDC 75498-275-16


Advanced Ingredient Data


Raw Label Data

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