NATOUCH ECZEMA WIPES- eczema wipes cloth

Natouch Eczema Wipes by

Drug Labeling and Warnings

Natouch Eczema Wipes by is a Otc medication manufactured, distributed, or labeled by Natouch LLC, SHAOXING ELITE BIO-TECH CO., LTD.. Drug facts, warnings, and ingredients follow.

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 ECZEMA WIPES 
eczema wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79073-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	3 g  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)	0.292 g  in 200 mL
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)	0.292 g  in 200 mL
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)	0.292 g  in 200 mL
ATRACTYLODES MACROCEPHALA WHOLE (UNII: 61Q25TS7LH)	0.292 g  in 200 mL
WATER (UNII: 059QF0KO0R)	146 g  in 200 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	2 g  in 200 mL
ROSA RUGOSA FLOWER (UNII: 969IQC5YJU)	10 g  in 200 mL
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)	0.292 g  in 200 mL
FU LING (UNII: XH37TWY5O4)	0.292 g  in 200 mL
BORNEOL (UNII: M89NIB437X)	0.097 g  in 200 mL
PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)	0.292 g  in 200 mL
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)	0.292 g  in 200 mL
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 200 mL
CENTELLA ASIATICA (UNII: 7M867G6T1U)	0.292 g  in 200 mL
COPTIS CHINENSIS WHOLE (UNII: 67444F3ESD)	0.049 g  in 200 mL
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)	0.146 g  in 200 mL
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)	0.486 g  in 200 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)	0.292 g  in 200 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79073-030-01	72 mL in 1 CANISTER; Type 0: Not a Combination Product	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/01/2023

Labeler - Natouch LLC (117545701)

Registrant - Natouch LLC (117545701)

Establishment
Name	Address	ID/FEI	Business Operations
SHAOXING ELITE BIO-TECH CO., LTD.		546459425	manufacture(79073-030)