ANTIBACTERIAL LOTIONTISSUE- benzalkonium chloride cloth

Antibacterial LotionTissue by

Drug Labeling and Warnings

Antibacterial LotionTissue 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%

Purpose

Antiseptic

Use

To help reduce bacteria on the skin that potentially can cause disease.

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 contacting with eyes. In case of eye contact rinse eyes thoroughly with water.

STOP USE

Stop Use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children if swallowed,get medical help or contact a poison control center right away.

Directions

Apply to face, nose and hands. Discard after use.

Children under 6 years of age should be supervised when using this product.

How to uses

Bag

Tear off the middle line of the bag and open the bag then take out of one sheet to use.Dispose the tissue to the trash bin after wiping.

Box

Open the box, take out of tissue as required.

Dispose it to the trash bin after use.

Inactive ingredients

Water, Glycerin, Aloe Barbadensis leaf extract.

Package Label - Principal Display Panel

NDC: 52489-003-01

NDC: 52489-003-02

NDC: 52489-003-03

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL LOTIONTISSUE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52489-003
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52489-003-01	35 mL in 1 BAG; Type 0: Not a Combination Product	01/29/2021
2	NDC: 52489-003-02	35 mL in 1 BOX; Type 0: Not a Combination Product	01/29/2021
3	NDC: 52489-003-03	46 mL in 1 BOX; Type 0: Not a Combination Product	01/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/29/2021

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(52489-003)