CALLINGTON ANTI-BACTERIAL HAND SANITISER- benzalkonium chloride cloth

Callington Anti-Bacterial Hand Sanitiser by

Drug Labeling and Warnings

Callington Anti-Bacterial Hand Sanitiser by is a Otc medication manufactured, distributed, or labeled by JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

BENZALKONIUM CHLORIDE  ..........  0.05%

Purpose

Antiseptic

Uses:

Antiseptic cleansing of hands to decrease bacteria on skin without the use of soap and water.

WARNINGS

For external use only.

• for external use only.
• do not use in eyes. If this occurs, rinse thoroughly with water.
• Stop use and ask a doctor if irritation o redness develops and persists for more than 72 hours.

Keep out of reach of children.

if swallowed get medical help or contact a Poison Control Center right away.

Directions

Tear open packedt, unfold and use as wash cloth. Allow hands to dry without wiping.

Inactive Ingredients:

Water, Propylene glycol, Polysorbate 20, Dipropylene glycol, Ethylhexylglycerin, Chlorphenesin, Bronopol, Citric acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALLINGTON ANTI-BACTERIAL HAND SANITISER 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71734-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
Water (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
BRONOPOL (UNII: 6PU1E16C9W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71734-210-01	4.2 g in 1 PACKAGE; Type 0: Not a Combination Product	02/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/04/2018

Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)

Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)

Establishment
Name	Address	ID/FEI	Business Operations
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.		544530534	MANUFACTURE(71734-210)