SPL v1
SPL
SPL Set ID aaf7dc74-f114-6167-e053-2995a90aee79
Route
TOPICAL
Published
Effective Date 2020-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 U)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

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: 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. 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

Daily cleaning of items and Antimicrobial


Medication Information

Purpose

Daily cleaning of items and Antimicrobial

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: 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. 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

This product is used to wipe hands, faces, skins, etc. It can be used on hands, skin, electronic products, office supplies, tableware, children's toys, and a variety of surfaces. Open the label, take out the wet towel, wipe the target area, and discard it in a trash receptacle. Close package immediately after use to maintain purity.

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:

  • 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.
  • 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 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

This product is used to wipe hands, skins, electronic products, office supplies, tableware, children's toys, and a variety of surfaces. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Warnings

Do not apply this product to red and swollen skin, wound, or any part sensitive to it. Keep this product out of children’s reach. If swallowed, get medical help or contact a Poison Control Center immediately. For external use only. Avoid contact with eyes & wounded skin. Discontinue use if irritation and redness develop. If the condition persists for more than 72 hours, consult a physician.

Store it in a cool and dry place. Flammable; avoid direct sunlight and open fire. And avoid contact with eyes and damaged skin.

Directions

Use it as needed, after following the usage instructions. For external use only.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Ethanol Alcohol, 75% v/v, antiseptic

Inactive Ingredients

Water

Package Label Principal Display Panel

010 mL NDC: 79935-001-10


Structured Label Content

Use

This product is used to wipe hands, faces, skins, etc. It can be used on hands, skin, electronic products, office supplies, tableware, children's toys, and a variety of surfaces. Open the label, take out the wet towel, wipe the target area, and discard it in a trash receptacle. Close package immediately after use to maintain purity.

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:

  • 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.
  • 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 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)

This product is used to wipe hands, skins, electronic products, office supplies, tableware, children's toys, and a variety of surfaces. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Purpose

Daily cleaning of items and Antimicrobial

Warnings

Do not apply this product to red and swollen skin, wound, or any part sensitive to it. Keep this product out of children’s reach. If swallowed, get medical help or contact a Poison Control Center immediately. For external use only. Avoid contact with eyes & wounded skin. Discontinue use if irritation and redness develop. If the condition persists for more than 72 hours, consult a physician.

Store it in a cool and dry place. Flammable; avoid direct sunlight and open fire. And avoid contact with eyes and damaged skin.

Directions

Use it as needed, after following the usage instructions. For external use only.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Ethanol Alcohol, 75% v/v, antiseptic

Inactive Ingredients (Inactive ingredients)

Water

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

010 mL NDC: 79935-001-10


Advanced Ingredient Data


Raw Label Data

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