COVIDEX- vernel kozmetik soap 
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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glycerin, sodium laureth sulfate, lauramine oxide, cocamidopropyl betaine, edetate sodium, water, citric acid monohydrate, polyquaternium-7,aloe vera leaf,cocamide, cetrimonium chloride,methylchloroisothiazolinone,styrene/ acrylamide copolymer, fragrance lavender& chia F-153480, alpha-tocopherol acetate, sodium chloride

Benzalkonium chloride 0.13 %

Antibacterial

For external use only ;only hands

avoid contact with eyes.If contact occurs,rinse eyes thoroughly with water

If swallowed, get medical help or contacta Poison Control Center right away

dosage form: soap

COVIDEX Antibacterial soap 450 mL backCOVIDEX Antibacterial soap 450 mL frontCOVIDEX Antibacterial soap 1000 mL backCOVIDEX Antibacterial soap 500 mL backCOVIDEX Antibacterial soap 1000 mL frontCOVIDEX Antibacterial soap 500 mL front

COVIDEX 
vernel kozmetik soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79652-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.1 mL  in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
LAURAMINE OXIDE (UNII: 4F6FC4MI8W) 3 mL  in 100 mL
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) 0.6 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
COCAMIDE (UNII: 3YXD33R71G) 2 mL  in 100 mL
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.5 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 mL  in 100 mL
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.1 mL  in 100 mL
SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 12 mL  in 100 mL
EDETATE SODIUM (UNII: MP1J8420LU) 0.05 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 74.9 mL  in 100 mL
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) 0.1 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.5 mL  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79652-003-01450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
2NDC:79652-003-02500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
3NDC:79652-003-031000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/02/2020
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(79652-003)

Revised: 11/2020
Document Id: b313a1c2-2326-8746-e053-2995a90a9928
Set id: b313a1c2-2325-8746-e053-2995a90a9928
Version: 1
Effective Time: 20201101
 
VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI