SERATIN

Manufacturer
VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-08-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:04

Label at a glance#

ProductCOVIDEX
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

alocohol 75% (v/v)

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INACTIVE INGREDIENT SECTION

purified water, carbomer, aloe vera leaf, fragrance lemon,trietanolamine (trolamine)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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 SECTION

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 SECTION

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

OTC - DO NOT USE SECTION

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

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

covidex gel 4 mL frontcovidex gel 4 mL frontcovidex gel 1000 mL frontcovidex gel 1000 mL frontcovidex gel 250 mL transparent bottle frontcovidex gel 250 mL transparent bottle frontcovidex gel 4 mL backcovidex gel 4 mL backcovidex gel 50 mL backcovidex gel 50 mL backcovidex gel 500 mL frontcovidex gel 500 mL frontcovidex gel 200 ml frontcovidex gel 200 ml frontcovidex gel 1000 ml backcovidex gel 1000 ml backcovidex gel 500 ml transparent bottle frontcovidex gel 500 ml transparent bottle frontcovidex gel 100 ml backcovidex gel 100 ml backcovidex gel 100 ml frontcovidex gel 100 ml frontcovidex gel 50 ml frontcovidex gel 50 ml frontcovidex gel 500 ml backcovidex gel 500 ml backcovidex gel 500 ml transparent bottle backcovidex gel 500 ml transparent bottle backcovidex gel 5 Lcovidex gel 5 Lcovidex gel 200 ml backcovidex gel 200 ml backcovidex 250 ml transparent bottle backcovidex 250 ml transparent bottle backcovidex gel 20 Lcovidex gel 20 L

OTC - ACTIVE INGREDIENT SECTION

alcohol 75 % (v/v)

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79652-005-01COVIDEX4 mL in 1 BAGGEL43
79652-005-02COVIDEX50 mL in 1 BOTTLE, PLASTICGEL503
79652-005-03COVIDEX100 mL in 1 BOTTLE, PLASTICGEL1003
79652-005-04COVIDEX200 mL in 1 BOTTLE, PLASTICGEL2003
79652-005-05COVIDEX250 mL in 1 BOTTLE, PLASTICGEL2503
79652-005-06COVIDEX500 mL in 1 BOTTLE, PLASTICGEL5003
79652-005-07COVIDEX1000 mL in 1 BOTTLE, PLASTICGEL10003
79652-005-08COVIDEX5000 mL in 1 BOTTLE, PLASTICGEL50003
79652-005-09COVIDEX20000 mL in 1 BOTTLE, PLASTICGEL200003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79652-005COVIDEX (VERNEL KOZMETIK) GEL [VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]3Legacy NDC, 9 package rows20201122_ac4f351a-e992-e22f-e053-2995a90ad0b1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b31dfb10-ab90-9514-e053-2995a90a5c86ac4f351a-e992-e22f-e053-2995a90ad0b12020-08-21WarningsExact identifier
spl id: b31dfb10-ab90-9514-e053-2995a90a5c86
spl set id: ac4f351a-e992-e22f-e053-2995a90ad0b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.