COVIDEX- vernel kozmetik soap

COVIDEX by

Drug Labeling and Warnings

COVIDEX by is a Otc medication manufactured, distributed, or labeled by VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

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

ACTIVE INGREDIENT

Benzalkonium chloride 0.13 %

PURPOSE

Antibacterial

WARNINGS

For external use only ;only hands

WHEN USING

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

STOP USE

• irritation or redness develops
• condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

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

dosage form: soap

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COVIDEX 
vernel kozmetik soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79652-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79652-003-01	450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2020
2	NDC: 79652-003-02	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2020
3	NDC: 79652-003-03	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/02/2020

Labeler - VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (519821634)

Registrant - VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (519821634)

Establishment
Name	Address	ID/FEI	Business Operations
VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		519821634	manufacture(79652-003)