ZIVA PERFUMED WIPES BAKHOOR- benzethonium chloride cloth

ZIVA PERFUMED WIPES BAKHOOR by

Drug Labeling and Warnings

ZIVA PERFUMED WIPES BAKHOOR 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:

Benzethonium Chloride 0.1%

PURPOSE

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

DOSAGE & ADMINISTRATION

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

Ingredients:

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

Product label

INGREDIENTS AND APPEARANCE

ZIVA PERFUMED WIPES BAKHOOR 
benzethonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81450-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81450-003-01	10 in 1 PACKAGE	12/24/2021
1		3.42 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(81450-003)