SPL v4
SPL
SPL Set ID b098d9b5-9f6d-2ea8-e053-2a95a90a7aef
Route
TOPICAL
Published
Effective Date 2020-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.5 mL)
Inactive Ingredients
Glycerin Carbomer 940 Water Aloe Vera Leaf Trolamine Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-30

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) 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. Glycerol (0.5% v/v). Aloe Vera Leaf (0.1% v/v). Carbomer 940 (0.33% v/v). Triethanolamin (0.2% v/v). Sterile distilled 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, Papilion Hygienic Antibacterial Hand Sanitizer


Medication Information

Purpose

Antiseptic, Papilion Hygienic Antibacterial Hand Sanitizer

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) 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. Glycerol (0.5% v/v). Aloe Vera Leaf (0.1% v/v). Carbomer 940 (0.33% v/v). Triethanolamin (0.2% v/v). Sterile distilled water The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Uses

Uses hand sanitizer to help reduce bacteria on the skin that could cause disease

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) 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.
  • Glycerol (0.5% v/v).
  • Aloe Vera Leaf (0.1% v/v).
  • Carbomer 940 (0.33% v/v).
  • Triethanolamin (0.2% v/v).
  • Sterile distilled 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 redness devolops and lasts.

Section 50567-7

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

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

Directions
  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years should be supervised when using this product.
Other Information
  • Store below 106 F (41 C).
  • May discolor certain fabrics or surfaces.
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine.

Package Label Principal Display Panel

500 mL NDC: 79262-110-02


Structured Label Content

Uses

Uses hand sanitizer to help reduce bacteria on the skin that could cause disease

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) 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.
  • Glycerol (0.5% v/v).
  • Aloe Vera Leaf (0.1% v/v).
  • Carbomer 940 (0.33% v/v).
  • Triethanolamin (0.2% v/v).
  • Sterile distilled 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 redness devolops and lasts.

Section 50567-7 (50567-7)

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Purpose

Antiseptic, Papilion Hygienic Antibacterial Hand Sanitizer

Warnings

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

Directions
  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years should be supervised when using this product.
Other Information (Other information)
  • Store below 106 F (41 C).
  • May discolor certain fabrics or surfaces.
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine.

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

500 mL NDC: 79262-110-02


Advanced Ingredient Data


Raw Label Data

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