ANTISEPTIC HAND WIPES- polyaminopropyl biguanide, benzalkonium and cetylpyridinium swab

antiseptic hand wipes by

Drug Labeling and Warnings

antiseptic hand wipes by is a Otc medication manufactured, distributed, or labeled by Jiebao Daily Chemical (Xiangxi)Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

POLYAMINOPROPYL BIGUANIDE 1.5%

BENZALKONIUM CHLORIDE 0.2%

CETYLPYRIDINIUM CHLORIDE 0.1%

Purpose

Antiseptic

USE

• For hand and skin cleaning
• Recommended for repeated use
• For use when soap and water are not available

Warning

• For external use only.
• When using this product, Do not use into eyes. In case of contact, rinse eyes thoroughly with water.

• Stop use and ask a doctor, if irritation and redness develops; Condition persists for more than 72 hours
• Do not use In children less than 2 months of age; On open skin wounds.

Other Information：

use in well ventilated areas; keep away from heat/sparks//open flames/hot surfaces

If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

citric acid, disodium EDTA, Lauryl Pyridinium chloride, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND WIPES 
polyaminopropyl biguanide, benzalkonium and cetylpyridinium swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78724-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) (POLYAMINOPROPYL BIGUANIDE - UNII:DT9D8Z79ET)	POLYAMINOPROPYL BIGUANIDE	15 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	2 mg  in 1 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78724-008-01	80 in 1 BAG	07/31/2020
1		4.70 g 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 not final	part333A	06/04/2020

Labeler - Jiebao Daily Chemical (Xiangxi)Co.,Ltd (405235017)

Establishment
Name	Address	ID/FEI	Business Operations
Jiebao Daily Chemical (Xiangxi)Co.,Ltd		405235017	manufacture(78724-008)