ZIVA PERFUMED WIPES GARDENIA- benzethonium chloride cloth

ZIVA PERFUMED WIPES GARDENIA by

Drug Labeling and Warnings

ZIVA PERFUMED WIPES GARDENIA 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 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, Pentylene Glycol and Glyceryl Caprylate / Caprate, Perfume, PEG 40 Hydrogenated Castor Oil, Benzethonium Chloride, Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA.

Product label

INGREDIENTS AND APPEARANCE

ZIVA PERFUMED WIPES GARDENIA 
benzethonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81450-007
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GARDENIA JASMINOIDES FLOWER (UNII: 2TU49609L2)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81450-007-01	10 in 1 PACKAGE	12/24/2021
1		3.42 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(81450-007)