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NDC 70031-0001-03 Antibacterial Wipes 0.3 g/100g Details

Antibacterial Wipes 0.3 g/100g

Antibacterial 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	70031-0001
Product ID	70031-001_da8e3936-9206-730c-e053-2995a90a5a73
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 Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzethonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	0.3
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 70031-0001-03 (70031000103)

Pricing Information	N/A
NDC Package Code	70031-001-03
Billing NDC	70031000103
Package	1 POUCH in 1 BOTTLE, PLASTIC (70031-001-03) / .0108 g in 1 POUCH
Marketing Start Date	2018-01-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1cb65ec8-4cbf-5d7f-e054-00144ff8d46c Details

Active ingredient

Benzalkonium chloride 0.3%

Purpose

Antiseptic

Use

hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

Flammabel.keep away from heat and flame.

do not use in the eyes,in case of caotact,rinse eyes thoroughly with water.

stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours.

Keep out of reach of children

if swallowed

get medical help or contact a Poison Control Center

Directions

tear open packet,remove and unfold wipe.

thoroughly wipe hands (palms ,backs and between fingers)

supervise children in use of this product

SPL UNCLASSIFIED SECTION

aloe barbadensis leaf juice,citric acid,disodium EDTA,ethyl alcohol ,fragrance,methylparaben,PEG-60 lanolin,PEG-dimethicone,potassium sorbate,propylparaben,quaternium-52,water(aqua)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WIPES

benzethonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70031-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETIC ACID (UNII: 9G34HU7RV0)
ALCOHOL (UNII: 3K9958V90M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70031-001-01	12 in 1 BAG	01/08/2018
1		0.0108 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:70031-001-02	1 in 1 BAG	01/08/2018
2		0.0108 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:70031-001-03	1 in 1 BOTTLE, PLASTIC	01/08/2018
3		0.0108 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:70031-001-04	5 in 1 BAG	01/08/2018
4		0.0108 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC:70031-001-06	6 in 1 BAG	01/08/2018
5		0.0108 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	08/05/2015

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(70031-001)

Revised: 3/2022

Document Id: da8e3936-9206-730c-e053-2995a90a5a73

Set id: 1cb65ec8-4cbf-5d7f-e054-00144ff8d46c

Version: 3

Effective Time: 20220319