Antibacterial Wipes

Manufacturer: Fitguard
Effective date: 2022-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:48:31

Label at a glance#

ProductAntibacterial Wipes

Active ingredientBENZALKONIUM CHLORIDE

Label structure9 sections

Indications and uses

For skin sanitizing to decrease the presence of bacteria - recommended for repeated use

Dosage and administration

Important! Do not open the top of the bag. 1. Cut a 1" opening into the top center of the bag along dashed line. 2. Pull out the center wipe from the bag through the 1" hole. 3. Place bag of wipes into the dispenser. 4. Thread the center wipe through the hole in the top of the dispenser. Take wipe and rub thoroughly over hands and other skin surfaces, allow to dry. Dispose of wipe after single use.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.30%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Phenoxyethanol, DMDM Hydantoin, Polysorbate 20, Ethylparaben, Methylparaben, Disodium EDTA, Sodium Citrate, Cetylpyridinium Chloride

Uses:

INDICATIONS & USAGE SECTION

For skin sanitizing to decrease the presence of bacteria - recommended for repeated use

Warnings:

WARNINGS SECTION

For external use only.

May irritate eyes.

Keep out of reach of children unless under adult supervision.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children unless under adult supervision.

Directions:

INSTRUCTIONS FOR USE SECTION

Important! Do not open the top of the bag.

1. Cut a 1" opening into the top center of the bag along dashed line.

2. Pull out the center wipe from the bag through the 1" hole.

3. Place bag of wipes into the dispenser.

4. Thread the center wipe through the hole in the top of the dispenser.

Take wipe and rub thoroughly over hands and other skin surfaces, allow to dry. Dispose of wipe after single use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Take wipe and rub thoroughly over hands and other skin surfaces, allow to dry. Dispose of wipe after single use.

B-Well Antibacterial Wipes, 800 Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

B-Well Wipes

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78494-002-01	2024-01-30	C162847	48780-1	d6a99b39-649a-a426-e053-dadaa90af4c2	B-Well Antibacterial Wipes, 800 Count
78494-002-01	2022-02-25	C162847	48780-1	d6a99b39-649a-a426-e053-dadaa90af4c2	B-Well Antibacterial Wipes, 800 Count
78494-002-01	2022-01-28	C162847	48780-1	d6a99b39-649a-a426-e053-dadaa90af4c2	B-Well Antibacterial Wipes, 800 Count

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78494-002-01	Antibacterial Wipes	1 in 1 BAG	CLOTH	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78494-002	ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) CLOTH [FITGUARD]	2	Legacy NDC, 1 package rows	20220226_b12dd9d8-4b2d-5497-e053-2a95a90a2e54.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Antibacterial Wipes
Benzalkonium Chloride
CETYLPYRIDINIUM CHLORIDE
PHENOXYETHANOL
DMDM HYDANTOIN
ETHYLPARABEN
BENZALKONIUM
WATER
POLYSORBATE 20
DISODIUM EDTA-COPPER
SODIUM CITRATE
METHYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
78494-002	78494-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
ETHYLPARABEN	14255EXE39	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
WATER	059QF0KO0R	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
DISODIUM EDTA-COPPER	6V475AX06U	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
METHYLPARABEN	A2I8C7HI9T	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d69bc489-73eb-5138-e053-2a95a90ae2e7			b12dd9d8-4b2d-5497-e053-2a95a90a2e54	2022-01-27	Warnings	Exact identifier spl id: d69bc489-73eb-5138-e053-2a95a90ae2e7 spl set id: b12dd9d8-4b2d-5497-e053-2a95a90a2e54

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.