Otc - Active Ingredient
alocohol 75% (v/v)
alcohol 75 % (v/v)
Covidex
FDA Label NDC 79652-005
10 label sections · Submitted to the FDA by Vernel Kozmetik Sanayi Ve Ticaret Anonim Sirketi · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vernel Kozmetik Sanayi Ve Ticaret Anonim Sirketi for the product Covidex (NDC 79652-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, inactive ingredient, otc - keep out of reach of children, other, indications & usage, warnings, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic, Hand Sanitizer
Inactive Ingredient
purified water, carbomer, aloe vera leaf, fragrance lemon,trietanolamine (trolamine)
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.
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
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.
Glycerol (1.45% 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.
Indications & Usage
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Warnings
For external use only. Flammable. Keep away from heat or flame
Otc - Do Not Use
in children less than 2 months of age
on open skin wounds
Storage And Handling
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
Package Label.Principal Display Panel
Covidex Gel 1000 mL Front (1000ml Front)
Covidex Gel 50 mL Back (50ml Back)
Covidex Gel 500 mL Front (500ml Front)
Covidex Gel 200 mL Front (200ml Front)
Covidex Gel 1000 mL Back (1000ml Back)
Covidex Gel 100 mL Back (100ml Back)
Covidex Gel 100 mL Front (100ml Front)
Covidex Gel 50 mL Front (50ml Front)
Covidex Gel 500 mL Back (500ml Back)
Covidex Gel 5 L (5lt)
Covidex Gel 200 mL Back (200ml Back)
Covidex Gel 20 L (20lt)
* Please review the disclaimer below.
