COVIDEX- vernel kozmetik gel 
VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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alocohol 75% (v/v)

Antiseptic, Hand Sanitizer

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

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

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.

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.

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

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

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

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alcohol 75 % (v/v)

COVIDEX 
vernel kozmetik gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79652-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 24.716 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.47 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.18 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.24 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.12 mL  in 100 mL
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.83 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79652-005-014 mL in 1 BAG; Type 0: Not a Combination Product08/21/2020
2NDC:79652-005-0250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2020
3NDC:79652-005-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2020
4NDC:79652-005-04200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2020
5NDC:79652-005-05250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2020
6NDC:79652-005-06500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2020
7NDC:79652-005-071000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2020
8NDC:79652-005-085000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2020
9NDC:79652-005-0920000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/21/2020
Labeler - VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (519821634)
Registrant - VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (519821634)
Establishment
NameAddressID/FEIBusiness Operations
VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI519821634manufacture(79652-005)

Revised: 8/2020
Document Id: b31dfb10-ab90-9514-e053-2995a90a5c86
Set id: ac4f351a-e992-e22f-e053-2995a90ad0b1
Version: 3
Effective Time: 20200821
 
VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI