ZIVA PERFUMED WIPES BAKHOOR- benzethonium chloride cloth 
Ziva Wetwipes FZCo

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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Drug Facts

Active Ingredient:

Benzethonium Chloride 0.1%

Direction for use:

Peel back the front label slowly. Pull wipes as needed. Reseal pouch by firmly running thumb over label 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 sun light. Prevent contact with eyes. In case of irritation wash away with water immediately.

Store below 25°C | For external use only | Keep out of reach of children

Ingredients:

Aqua, Pentylene Glycol and Glyceryl Caprylate / Caprate, Perfume, PEG 40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA.

Product label

image description

ZIVA PERFUMED WIPES BAKHOOR 
benzethonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81450-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SANTALUM ALBUM SEED OIL (UNII: J8A90C3A98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81450-003-0110 in 1 PACKAGE12/24/2021
13.42 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/24/2021
Labeler - Ziva Wetwipes FZCo (559186188)
Registrant - Dirra USA (117678868)
Establishment
NameAddressID/FEIBusiness Operations
Ziva Wetwipes FZCO559186188manufacture(81450-003)

Revised: 12/2021
Document Id: d3d752b9-6d47-1432-e053-2a95a90a9071
Set id: 711fe2af-6785-4f5b-94e7-6b11b4a140e8
Version: 1
Effective Time: 20211223
 
Ziva Wetwipes FZCo