Natouch Antifungal Wipes Plus

Natouch Antifungal Wipes Plus
SPL v18
SPL
SPL Set ID a85cb307-b3ad-1584-e053-2995a90a9a70
Route
TOPICAL
Published
Effective Date 2020-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 g) Menthol, Unspecified Form (1 g)
Inactive Ingredients
Propylene Glycol Lavender Oil Water Tea Tree Oil Aloe Vera Leaf Polysaccharides Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-01

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) (80%, 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 (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, Antifungal Wet Wipes

Dosage and Administration

Rub the sheet on certain skin areas. Supervise children under 6 years of age when using this product to avoid swallowing.


Medication Information

Purpose

Antiseptic, Antifungal Wet Wipes

Dosage and Administration

Rub the sheet on certain skin areas.

Supervise children under 6 years of age when using this product to avoid swallowing.

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) (80%, 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 (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

Wet Wipes to help reduce microbes that potentially can cause disease. For use when soap and water are not available. Also can be used for treat skin disease caused by fungus, such as jock itch, athlete's foot or ringworm.

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) (80%, 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 (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 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.

Warnings

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

Directions
  • Rub the sheet on certain skin areas needed to be cleaned or infected with fungus
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
  • You are known to be allergy to any ingredients.
Other Information

Store at 20-25oC (68-77 oF). Avoid Excessive Moisture.

Inactive Ingredients

glycerin,Menthol, Eucalyptol, Propylene Glycol, Glycerol, lavender oil, Aloe Vera, purified water USP

Package Label Principal Display Panel

60 sheets Canister NDC: 79073-001-60


Structured Label Content

Use

Wet Wipes to help reduce microbes that potentially can cause disease. For use when soap and water are not available. Also can be used for treat skin disease caused by fungus, such as jock itch, athlete's foot or ringworm.

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) (80%, 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 (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 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.

Purpose

Antiseptic, Antifungal Wet Wipes

Warnings

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

Directions
  • Rub the sheet on certain skin areas needed to be cleaned or infected with fungus
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
  • You are known to be allergy to any ingredients.
Other Information

Store at 20-25oC (68-77 oF). Avoid Excessive Moisture.

Inactive Ingredients (Inactive ingredients)

glycerin,Menthol, Eucalyptol, Propylene Glycol, Glycerol, lavender oil, Aloe Vera, purified water USP

Dosage and Administration

Rub the sheet on certain skin areas.

Supervise children under 6 years of age when using this product to avoid swallowing.

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

60 sheets Canister NDC: 79073-001-60


Advanced Ingredient Data


Raw Label Data

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