walter's 1893 hand sanitizer alcohol antiseptic 75% topical solution

walter's 1893 hand sanitizer alcohol antiseptic 75% topical solution
SPL v3
SPL
SPL Set ID b8e4eaca-a9d6-924f-e053-2a95a90aa445
Route
topical
Published
Effective Date 2021-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.3 mL)
Inactive Ingredients
polyacrylic acid (250000 mw) propylene glycol trolamine water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-01-30

Purpose

Antiseptic

Description

This is a hand sanitizer manufactured using the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation): 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. Propylene glycol (2.5% v/v). Polyacrylic acid (0.3% v/v). Triethanolamine (0.3% v/v). Sterile distilled water (21.9% v/v). The firm does not add other active or inactive ingredients.


Medication Information

Warnings

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

Purpose

Antiseptic

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)
Inactive Ingredients

propylene glycol , polyacrylic acid, triethanolamine, purified water USP

Description

This is a hand sanitizer manufactured using the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation): 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. Propylene glycol (2.5% v/v). Polyacrylic acid (0.3% v/v). Triethanolamine (0.3% v/v). Sterile distilled water (21.9% v/v). The firm does not add other active or inactive ingredients.

Use

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

Section 42229-5

This is a hand sanitizer manufactured using the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

  • 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.
  • Propylene glycol (2.5% v/v).
  • Polyacrylic acid (0.3% v/v).
  • Triethanolamine (0.3% v/v).
  • Sterile distilled water (21.9% v/v).

The firm does not add other active or inactive ingredients.

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
Label Panel Image

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

500 mL NDC: 81093-002-01

998mL NDCL 81093-002-02


Structured Label Content

Warnings

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

Purpose

Antiseptic

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)
Inactive Ingredients (Inactive ingredients)

propylene glycol , polyacrylic acid, triethanolamine, purified water USP

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)

This is a hand sanitizer manufactured using the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

  • 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.
  • Propylene glycol (2.5% v/v).
  • Polyacrylic acid (0.3% v/v).
  • Triethanolamine (0.3% v/v).
  • Sterile distilled water (21.9% v/v).

The firm does not add other active or inactive ingredients.

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
Label Panel Image (Label panel image)

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

500 mL NDC: 81093-002-01

998mL NDCL 81093-002-02


Advanced Ingredient Data


Raw Label Data

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