ANTIBACTERIAL WET WIPES- benzethonium chloride swab
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY

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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70031-003 Antibacterial Wet Wipes

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 ontinues 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 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.

INACTIVE INGREDIENT

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

ANTIBACTERIAL WET WIPES
benzethonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70031-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.115 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
QUATERNIUM-22 (UNII: MXO138JCBP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CITRACONIC ACID (UNII: 0RQ6CXO9KD)
ALCOHOL (UNII: 3K9958V90M)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-60 CASTOR OIL (UNII: VXP26NM2XX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70031-003-01	1 in 1 PACKAGE	01/08/2018
1		3 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:70031-003-02	10 in 1 PACKAGE	01/08/2018
2		3 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:70031-003-03	3 in 1 BAG	01/08/2018
3		10 in 1 PACKAGE
3		3 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:70031-003-04	20 in 1 BOX	01/08/2018
4		1 in 1 PACKAGE
4		3 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/10/2016

Labeler - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)

Registrant - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)

Name	Address	ID/FEI	Business Operations
Establishment
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY		679914791	manufacture(70031-003)