ZIVA WATER WIPES- benzalkonium chloride cloth

ZIVA WATER WIPES by

Drug Labeling and Warnings

ZIVA WATER 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 0.01%

PURPOSE

Direction for use

For external use only. Open the flip top & peel back the front label slowly. Pull one wipe at a time. Gently cleanse your baby's skin using one or more wipes. Reseal pouch by firmly running thumb over label and 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

Other information

Store below 25°C 

Ingredients

Aqua, Pyrus Malus (apple) fruit extract, Benzalkonium Chloride.

Product label

INGREDIENTS AND APPEARANCE

ZIVA WATER WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81450-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.01 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
APPLE FRUIT OIL (UNII: 9NT987I3A8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81450-006-01	100 in 1 PACKAGE	12/24/2021
1		6.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/24/2021

Labeler - Ziva Wetwipes FZCo (559186188)

Registrant - Dirra USA (117678868)

Establishment
Name	Address	ID/FEI	Business Operations
Ziva Wetwipes FZCO		559186188	manufacture(81450-006)