ANTIBACTERIAL WIPES- benzalkonium chloride cloth

Antibacterial Wipes by

Drug Labeling and Warnings

Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by Imperial Palace Commodity (shenzhen) Co., Ltd, Imperial Palace Commodity(Dongguan) CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient(s)

Benzalkonium chloride ：0.13% (W/W)

Purpose

Antibacterial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Do not use

Do not use if you are allergic to any of the ingredients.

WHEN USING

When using this product avoid contact with eyes. In case of eye contact,flush thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children. If swallowed, get medical help or contact a Poision Control Center right away.

Directions

Adults and children 6 years and over :

Wet hands thoroughly with wipes and allow to dry, dispose of used wipe in trash, don not flush

Children under 6 years:

ask a doctor before use.

How to uses

Packs

●Peel back lid and then label.

●Remove wipes as required.

●Replace lid and label to keep wipes moist.

Buckets

●Open the bucket lid from the top.

●Locate tear cut in the inner pouch, tear straight to open. Do not remove wipesroll from pouch.

●Pull first wipes from center of roll up through opening.

●Thread first wipe through dispensing nozzle in top of roll.

●Close the bucket lid and dispense the wipes as required.

Inactive ingredients

●Water(Aqua)

●Cetylpyridinium chloride

●Chlorphenesin

●Ethylhexylglycerin

●Propylene glycol

●Glycerol

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52489-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
WATER (UNII: 059QF0KO0R)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52489-002-01	360 mL in 1 PACKAGE; Type 0: Not a Combination Product	05/27/2020
2	NDC: 52489-002-02	370 mL in 1 PAIL; Type 0: Not a Combination Product	05/27/2020
3	NDC: 52489-002-03	940 mL in 1 PAIL; Type 0: Not a Combination Product	05/27/2020
4	NDC: 52489-002-04	3000 mL in 1 PAIL; Type 0: Not a Combination Product	05/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2020

Labeler - Imperial Palace Commodity (shenzhen) Co., Ltd (527796368)

Registrant - Imperial Palace Commodity(Dongguan) CO.,LTD (544367643)

Establishment
Name	Address	ID/FEI	Business Operations
Imperial Palace Commodity(Dongguan) CO.,LTD		544367643	manufacture(52489-002)