ZIVA BABY WIPES- zinc oxide cloth 
Ziva Wetwipes FZCo

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Drug Facts

Active Ingredient:

Zinc Oxide 0.1%

Direction for use

Peel back the front label or open  the flip top slowly. Pull wipes as needed. Gently cleanse your baby's skin using one or more wipes. Reseal pouch by firmly running thumb over label to close the flip top to prevent moisture loss.

Precautions:

For external use only. 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.

Keep out of rech of children

Store below 25°C

Ingredients:

Aqua, Zinc Oxide, Pentylene Glycol and Glyceryl Caprylate / Caprate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Propylene Glycol, Sodium cocoamphoacetate, Disodium cocoamphodiacetate,  Cocamidoproply Betaine, PEG 40 Hydrogenated Castor Oil, Chamomile Extract, PEG-120 Methyl Glucose Dioleate,  Disodium EDTA, Citric Acid.

Product label

image description

ZIVA BABY WIPES 
zinc oxide cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81450-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
CHAMOMILE (UNII: FGL3685T2X)  
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81450-005-0180 in 1 PACKAGE12/24/2021
14.59 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00312/24/2021
Labeler - Ziva Wetwipes FZCo (559186188)
Registrant - Dirra USA (117678868)
Establishment
NameAddressID/FEIBusiness Operations
Ziva Wetwipes FZCO559186188manufacture(81450-005)

Revised: 10/2023
Document Id: 06fdbe50-9363-a608-e063-6394a90a4088
Set id: 5ae9d3a9-bef4-45fb-ac71-7ee0be72856c
Version: 4
Effective Time: 20231005
 
Ziva Wetwipes FZCo