FDA Label for Deep Fresh Antiviral Alcohol Wipes
View Indications, Usage & Precautions
Deep Fresh Antiviral Alcohol Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Aksan Kozmetik Sanayi Ve Ticaret Anonim Sirketi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- 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.
- DICAPRYLYL CARBONATE (0.01 % v/v).
- OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (0.1 % v/v).
- POLYSORBATE 20 (0.2 % v/v).
- GLYCERYL OLEATE (0.01 % v/v).
- LAURYL GLUCOSIDE (0.1 % v/v).
- FATTY-ACID AMIDE HYDROLASE(0.1 % v/v).
- GLYCERIN (0.5 % v/v).
- PANTHENOL (0.1 % v/v).
- 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
Otc - 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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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
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