ART NATURALS- hand sanitizing wipes, ethanol cloth

Art Naturals by

Drug Labeling and Warnings

Art Naturals by is a Otc medication manufactured, distributed, or labeled by SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI. 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. Isopropyl Alcohol (75%, 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)

Ethanol 75% Purpose: Antiseptic

Purpose

Antiseptic

Use

Single use wipes to reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

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

Do not use

These wipes do not replace wipes used for medical procedures

WHEN USING

If eye contact occurs flush eyes with water

STOP USE

Stop use if irritation and redness develop. If condition continues, consult your health care practitioner

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

Unfold towelette, wipe hands, discard after use

Other information

• Store at room Temperature 59-86F

Inactive ingredients

Water

Package Label - Principal Display Panel

50 pcs

200 gr NDC: 81406-002-50

Hand Sanitizing Wipes- 50 pcs
NDC: 81406-002-50

Hand Sanitizing Wipes- 50 pcs-200 gr

NDC: 81406-002-50

INGREDIENTS AND APPEARANCE

ART NATURALS 
hand sanitizing wipes, ethanol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81406-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	25 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81406-002-50	200 g in 1 POUCH; Type 0: Not a Combination Product	02/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/15/2021

Labeler - SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI (366438166)

Registrant - SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI (366438166)

Establishment
Name	Address	ID/FEI	Business Operations
SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI		366438166	manufacture(81406-002)