DEEP FRESH ANTIVIRAL ALCOHOL WIPES- alcohol cloth

Deep Fresh Antiviral Alcohol Wipes by

Drug Labeling and Warnings

Deep Fresh Antiviral Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by AKSAN KOZMETIK 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, 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. DICAPRYLYL CARBONATE (0.01 % v/v).
3. OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (0.1 % v/v).
4. POLYSORBATE 20 (0.2 % v/v).
5. GLYCERYL OLEATE (0.01 % v/v).
6. LAURYL GLUCOSIDE (0.1 % v/v).
7. FATTY-ACID AMIDE HYDROLASE(0.1 % v/v).
8. GLYCERIN (0.5 % v/v).
9. PANTHENOL (0.1 % v/v).
10. 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 75% v/v. Purpose: Antiseptic/ Antiviral

Purpose

Antiseptic/Antiviral, Hand Sanitizer

Use

Hand Sanitizer wet wipes to help 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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using In case of swallowing, rinse mouth with plenty of water. Get medical advise. In case of contact with eyes, If you are wearing contact lenses, remove them immediately. Rinse your eyes with plenty of clean water. Get medical attention if symptoms persist.

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.

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

• Open the cap and get enough wipes from inside. Wipe your hands gently with the wipes.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Dicaprylyl Carbonate, Glycerin, Glyceryl Oleate, Lauryl Glucoside, Olus Oil, Panthenol, Parfum, Polyglyceryl-2 Dipolyhydroxystearate, Polysorbate 20, Water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DEEP FRESH ANTIVIRAL ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86815-006
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)	0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)	0.1 mL  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.2 mL  in 100 mL
OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (UNII: X0S2P50TYC)	0.1 mL  in 100 mL
GLYCERYL OLEATE (UNII: 4PC054V79P)	0.01 mL  in 100 mL
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)	0.1 mL  in 100 mL
FATTY-ACID AMIDE HYDROLASE 1 (UNII: E747F394ZQ)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86815-006-01	15 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 86815-006-02	56 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 86815-006-04	500 mL in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
4	NDC: 86815-006-03	80 mL in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)

Registrant - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)

Establishment
Name	Address	ID/FEI	Business Operations
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		365577706	manufacture(86815-006)