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NDC 70031-0003-04 Antibacterial Wet Wipes 0.115 g/100g Details

Antibacterial Wet Wipes 0.115 g/100g

Antibacterial Wet Wipes is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY. The primary component is BENZETHONIUM CHLORIDE.

Product Information

NDC	70031-0003
Product ID	70031-003_da8daf04-fa21-2ea3-e053-2a95a90a2761
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Antibacterial Wet Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzethonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	0.115
Active Ingredient Units	g/100g
Substance Name	BENZETHONIUM CHLORIDE
Labeler Name	TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70031-0003-04 (70031000304)

Pricing Information	N/A
NDC Package Code	70031-003-04
Billing NDC	70031000304
Package	20 PACKAGE in 1 BOX (70031-003-04) / 1 POUCH in 1 PACKAGE / 3 g in 1 POUCH
Marketing Start Date	2018-01-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2db1d3d7-735b-61f3-e054-00144ff88e88 Details

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)

Revised: 3/2022

Document Id: da8daf04-fa21-2ea3-e053-2a95a90a2761

Set id: 2db1d3d7-735b-61f3-e054-00144ff88e88

Version: 3

Effective Time: 20220319