NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET cloth

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

1. 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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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.

Active Ingredient(s): Alcohol, Tolnaftate

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.

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.

STOP USE

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

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

Package Label - Principal Display Panel

60 sheets Canister NDC: 79073-001-60

INGREDIENTS AND APPEARANCE

NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET 
nabrace wipes for ringworm, jockitch and athlete feet cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84056-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	2 g  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)	1 g  in 200 mL
WATER (UNII: 059QF0KO0R)	81 g  in 200 mL
TEA TREE OIL (UNII: VIF565UC2G)	2 g  in 200 mL
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)	1 g  in 200 mL
GLYCERIN (UNII: PDC6A3C0OX)	3 g  in 200 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	10 g  in 200 mL
MENTHOL (UNII: L7T10EIP3A)	2 g  in 200 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84056-004-05	5 in 1 BAG	07/01/2020
1		30 mL in 1 BAG; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	07/01/2020

Labeler - Nabrace LLC (119189241)

Registrant - Nabrace LLC (119189241)

Establishment
Name	Address	ID/FEI	Business Operations
SHAOXING ELITE BIO-TECH CO., LTD.		546459425	manufacture(84056-004)