Nabrace Wipes For Ringworm, Jockitch And Athlete Feet Cloth
FDA Label NDC 84056-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nabrace Llc for the product Nabrace Wipes For Ringworm, Jockitch And Athlete Feet (NDC 84056-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Dosage And Administration

→ Package Label - Principal Display Panel

Other

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

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.

Warnings

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

Do Not Use

in children less than 2 months of age
on open skin wounds
You are known to be allergy to any ingredients.

Otc - When Using

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.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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

Directions

Rub the sheet on certain skin areas needed to be cleaned or infected with fungus

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

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

60 sheets Canister NDC: 79073-001-60

* Please review the disclaimer below.

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