ZIVA ANTIBACTERIAL MULTIPURPOSE WIPES- benzalkonium chloride cloth

ZIVA ANTIBACTERIAL MULTIPURPOSE WIPES by

Drug Labeling and Warnings

ZIVA ANTIBACTERIAL MULTIPURPOSE WIPES by is a Otc medication manufactured, distributed, or labeled by Ziva Wetwipes FZCo, Dirra USA, Ziva Wetwipes FZCO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

PURPOSE

Direction of use:

Open the flip top / peel back the front label slowly. Pull wipes as needed. Reseal pouch by firmly running thumb over label / close the flip top to prevent moisture loss.

Precautions:

Do not apply to irritated or damaged skin. In case of gluteal erythema (redness of skin), contact your doctor or pharmacist. Keep in a cool place away from direct sunlight. Prevent contact with eyes. In case of irritation wash away with water immediately.

DOSAGE & ADMINISTRATION

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

Ingredients:

Aqua, Pentylene Glycol and Glyceryl Caprylate / Caprate, Dimethicone copolyol, PEG 40 Hydrogenated Castor Oil, Tocopheryl Acetate (Vitamin E), Glycerine, Sodium cocoamphodiacetate, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, Aloe Barbadensis Leaf Juice.

Product label

INGREDIENTS AND APPEARANCE

ZIVA ANTIBACTERIAL MULTIPURPOSE WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81450-002
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81450-002-01	80 in 1 PACKAGE	12/24/2021
1		4.59 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	12/24/2021

Labeler - Ziva Wetwipes FZCo (559186188)

Registrant - Dirra USA (117678868)

Establishment
Name	Address	ID/FEI	Business Operations
Ziva Wetwipes FZCO		559186188	manufacture(81450-002)