ANTIBACTERIAL WET WIPES- benzalkonium chloride swab
Hebei Yihoucheng Commodity Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Benzalkonium chloride 0.115%

Purpose

Antibacterial

Use

decreases bacteria on skin

Warnings

For external use only.
Do not use over large areas of the body
if you are allergic to any of the ingredients.
When using this product do not get into eyes.
If contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash
develops and continues for more than 72 hours.
Keep out of reach of children.
If swallowed, get medical help or contact
a Poison Control Center right away.

Keep out of reach of children

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

Directions

For adults and children of 2 years and over use
on hands and face to clean and refresh, allow
skin to air dry.
For children under 2 years ask a doctor before use.

Water,SD Alcohol 40,Propylene Glycol,Aloe Barbadensis Leaf,Potassium sorbate,Tocopherol,Quaternium 52,PEG-60 Lanolin,Citric Acid,Disodium EDTA

ANTIBACTERIAL WET WIPES
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59575-501
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM)	BENZALKONIUM CHLORIDE	0.115 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL
ALOE VERA LEAF
ALCOHOL
POTASSIUM SORBATE
TOCOPHEROL
QUATERNIUM-22
PEG-60 CASTOR OIL
CITRACONIC ACID
DISODIUM EDTA-COPPER
Water

Packaging
#	Item Code	Package Description
1	NDC:59575-501-01	10 in 1 PACKAGE
1		3 g in 1 POUCH
2	NDC:59575-501-02	1 in 1 PACKAGE
2		3 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/16/2013

Labeler - Hebei Yihoucheng Commodity Co.,Ltd. (529305333)

Establishment
Name	Address	ID/FEI	Business Operations
Hebei Yihoucheng Commodity Co.,Ltd.		529305333	manufacture(59575-501)

Revised: 08/2013

Document Id: 5ec0ca95-4d0c-4a67-ad83-cb3b3c693881

Set id: 8d635665-05b2-488d-a0cc-e0081e8adb71

Version: 1

Effective Time: 20130817

Hebei Yihoucheng Commodity Co.,Ltd.