NATOUCH ANTIFUNGAL WIPES PLUS- antifungal antiseptic wipes plus cloth

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

NATOUCH ANTIFUNGAL WIPES PLUS
antifungal antiseptic wipes plus cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79073-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	2 g in 200 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL	2 g in 200 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	10 g in 200 mL
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 79073-007-80	80 mL in 1 CANISTER; Type 0: Not a Combination Product	07/01/2020

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

Labeler - Natouch LLC (117545701)

Registrant - Natouch LLC (117545701)

Name	Address	ID/FEI	Business Operations
Establishment
SHAOXING ELITE BIO-TECH CO., LTD.		546459425	manufacture(79073-007)

NATOUCH ANTIFUNGAL WIPES PLUS- antifungal antiseptic wipes plus cloth

Natouch Antifungal Wipes Plus by

Drug Labeling and Warnings

Drug Details [pdf]