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NDC 40562-0010-01 ALCOHOL-FREE SANITIZING WIPES 0.13 mg/100mL Details

ALCOHOL-FREE SANITIZING WIPES 0.13 mg/100mL

ALCOHOL-FREE SANITIZING WIPES is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Anhui Hanbon Daily Chemical Co., Ltd.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	40562-0010
Product ID	40562-010_d63a39b3-73c3-5183-e053-2995a90a2cd3
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	ALCOHOL-FREE SANITIZING WIPES
Proprietary Name Suffix	n/a
Non-Proprietary Name	SANITIZING WIPES
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	mg/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Anhui Hanbon Daily Chemical Co., Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 40562-0010-01 (40562001001)

Pricing Information	N/A
NDC Package Code	40562-010-01
Billing NDC	40562001001
Package	20 PATCH in 1 PACKET (40562-010-01) / 4 mL in 1 PATCH
Marketing Start Date	2020-07-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aa91a0b7-4dcc-0e1b-e053-2995a90a9f26 Details

Active Ingredient(s)

Benzalkonium Chloride 0.13mg in 100mL

Purpose

Antibacterial

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use

in the eyes.
if you are allergic to any of the ingredients.

SPL UNCLASSIFIED SECTION

If eye contact occurs, rinse thoroughly with water.

SPL UNCLASSIFIED SECTION

If irritation or redness develops and persist for more than 72 hours.

SPL UNCLASSIFIED SECTION

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

Directions

Storage. Store at room temperature.
Dispensing. Peel back from label. Remove wipe(s). Reseal by pressing label over opening.
Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.

Inactive ingredients

Water, Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Polysorbate 20, Polyaminopropyl Biguanide, 2-bromo-2-nitropropane-1,3-diol, Tocopheryl Acetate, Citric Acid.

Package Label - Principal Display Panel

20 PATCH in 1 PACKET NDC: 40562-010-01

INGREDIENTS AND APPEARANCE

ALCOHOL-FREE SANITIZING WIPES

sanitizing wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:40562-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BRONOPOL (UNII: 6PU1E16C9W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:40562-010-01	20 in 1 PACKET	07/16/2020
1		4 mL in 1 PATCH; 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	part333E	07/16/2020

Labeler - Anhui Hanbon Daily Chemical Co., Ltd. (405624856)

Name	Address	ID/FEI	Business Operations
Establishment
Anhui Hanbon Daily Chemical Co., Ltd.		405624856	manufacture(40562-010)

Revised: 1/2022

Document Id: d63a39b3-73c3-5183-e053-2995a90a2cd3

Set id: aa91a0b7-4dcc-0e1b-e053-2995a90a9f26

Version: 2

Effective Time: 20220123

Search by Drug Name or NDC

NDC 40562-0010-01 ALCOHOL-FREE SANITIZING WIPES 0.13 mg/100mL Details

ALCOHOL-FREE SANITIZING WIPES 0.13 mg/100mL

Product Information

Package

Package Images

NDC 40562-0010-01 (40562001001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL aa91a0b7-4dcc-0e1b-e053-2995a90a9f26 Details

Active Ingredient(s)

Purpose

Use

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Inactive ingredients

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

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