ANTIBACTERIAL WET WIPES- benzalkonium chloride swab

ANTIBACTERIAL WET WIPES by

Drug Labeling and Warnings

ANTIBACTERIAL WET WIPES by is a Otc medication manufactured, distributed, or labeled by LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Antibacterial

WARNINGS

For external use only.Keep out of the eyes. In case of eye contact, rinse with water.If irritation develps discontinue use and consult a doctor if irritation persists more than 72 hours. If swallowed, seek medical attention or contact a Poison Control Center.

INACTIVE INGREDIENT

Aqua, Glycerin, Phenoxyethanol, Parfum, Polysorbate 20, Sodium PCA, Tetrasodium EDTA, Ethylhexylglycerin, Citric Acid

ACTIVE INGREDIENT

Benzalkonium chloride 0.13%

INDICATIONS & USAGE

decreases bacteria on skin. recommended for repeated use

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children, except with adult supervision.

DOSAGE & ADMINISTRATION

Take wipe and rub thoroughly over all surfaces of both hands.Rrub hands together briskly to dry·dispose of wipe. For children under 2 years ask a doctor before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WET WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77892-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIMETHYLENEDIAMINETETRAACETIC ACID (UNII: 3F6OA94EER)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77892-0002-1	3 g in 1 POUCH; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN (502952094)

Establishment
Name	Address	ID/FEI	Business Operations
LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN		502952094	manufacture(77892-0002)