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 sunlight. Prevent contact with eyes. In case of irritation wash away with water immediately.

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

image description

ZIVA PERFUMED WIPES GARDENIA
benzethonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81450-007
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	12/24/2021

Labeler - Ziva Wetwipes FZCo (559186188)

Registrant - Dirra USA (117678868)

Name	Address	ID/FEI	Business Operations
Establishment
Ziva Wetwipes FZCO		559186188	manufacture(81450-007)