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NDC 77070-0701-20 Antimicrobial Hand Wipes 0.125 g/100g Details

Antimicrobial Hand Wipes 0.125 g/100g

Antimicrobial Hand Wipes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Goodfibers. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	77070-0701
Product ID	77070-701_d6268ccf-2f62-9946-e053-2995a90acfbd
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	Antimicrobial Hand Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	Antimicrobial Hand Wipes
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.125
Active Ingredient Units	g/100g
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Goodfibers
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 77070-0701-20 (77070070120)

Pricing Information	N/A
NDC Package Code	77070-701-20
Billing NDC	77070070120
Package	1 g in 1 POUCH (77070-701-20)
Marketing Start Date	2020-07-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aa2ff105-04cd-54a1-e053-2a95a90abc5a Details

Active Ingredient

Benzalkonium Chloride 0.125%

Purpose

Pupose

Antimicrobial

Uses

* For hand washing to decrease bacteria on skin without requiring water or rinsing

* Recommended for repeated use

Warnings

For external use only

When using this product

* Do not use in or near eyes

If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor

*If irritation and redness persist for more than 72 hours

Keep Out of reach of children

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

* Wet thoroughly hands with wipe and allow to dry without wiping.

* Children under six years of age should be supervised when using this product

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, Decyl Glucoside, Fragrance, Phenoxyethanol, Potassium Sorbate, Tetrasodium EDTA, Water.

Principal Display Panel

KILLS 99.9% OF GERMS

all clear

Antibacterial Hand Wipes

Helps keep hands clean while on-the-go

7 x 5.1in (18 x 13cm)

20ct

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL HAND WIPES

antimicrobial hand wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77070-701
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.125 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77070-701-20	1 g in 1 POUCH; Type 0: Not a Combination Product	07/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/11/2020

Labeler - Goodfibers (105870470)

Registrant - Goodfibers (105870470)

Name	Address	ID/FEI	Business Operations
Establishment
Goodfibers		105870470	manufacture(77070-701)

Revised: 1/2022

Document Id: d6268ccf-2f62-9946-e053-2995a90acfbd

Set id: aa2ff105-04cd-54a1-e053-2a95a90abc5a

Version: 3

Effective Time: 20220122