SPL v3
SPL
SPL Set ID ca5006ec-1f43-c310-e053-2995a90a2556
Route
TOPICAL
Published
Effective Date 2021-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.7 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-25

Description

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Use

For preparation of the skin prior to injection.

Section 42229-5

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation and redness develops.

Section 50567-7

When using this product do not get into eyes. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites or serious burns, consult a doctor. use only in a well ventilated area.

Section 77291-3

If pregnant or breastfeeding ask a health professional before use.

Warnings

For external use only. Flammable,keep away from fire or flame.

Directions
  • Apply to skin as needed.
  • Discard after single use.
Do Not Use
  • with electrocautery procedures.
Other Information
  • Store at room temperature 15-30C (59-86F)
Active Ingredient(s)

Isopropyl Alcohol, 70% v/v

Inactive Ingredients

Water

Package Label Principal Display Panel

NDC: 82167-000


Structured Label Content

Use

For preparation of the skin prior to injection.

Section 42229-5 (42229-5)

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Section 50565-1 (50565-1)

Keep out of reach of children. If accidentally 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 and redness develops.

Section 50567-7 (50567-7)

When using this product do not get into eyes. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites or serious burns, consult a doctor. use only in a well ventilated area.

Section 77291-3 (77291-3)

If pregnant or breastfeeding ask a health professional before use.

Purpose

Antiseptic

Warnings

For external use only. Flammable,keep away from fire or flame.

Directions
  • Apply to skin as needed.
  • Discard after single use.
Do Not Use (Do not use)
  • with electrocautery procedures.
Other Information (Other information)
  • Store at room temperature 15-30C (59-86F)
Active Ingredient(s)

Isopropyl Alcohol, 70% v/v

Inactive Ingredients (Inactive ingredients)

Water

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

NDC: 82167-000


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)