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NDC 72976-0006-01 Antiseptic Towelette 1.3 mg/mL Details

Antiseptic Towelette 1.3 mg/mL

Antiseptic Towelette is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Ever Ready First Aid. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	72976-0006
Product ID	72976-006_ec15d829-8ac1-5d19-e053-2995a90a1c64
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	Antiseptic Towelette
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Ever Ready First Aid
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 72976-0006-01 (72976000601)

Pricing Information	N/A
NDC Package Code	72976-006-01
Billing NDC	72976000601
Package	1.6 mL in 1 POUCH (72976-006-01)
Marketing Start Date	2022-10-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ec15d51e-8a1f-3e5c-e053-2995a90a7774 Details

Active ingredients

Benzalkonium chloride, 0.13%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use

in the eyes or apply over large areas of the body.

Stop use

if irritation, redness or other symptoms develop.

Consult a doctor if the condition persists or gets worse.

Keep out of reach of children.

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

Directions

Open packet, unfold and use as a washcloth.

Inactive ingredients

Purified water

Other information

Store at room temperature: 15°-30°C (59°-86°F)

SPL UNCLASSIFIED SECTION

PROFESSIONAL USE

BZK Antiseptic Towelette

• Apply topically as needed

• Sterile unless pouch is opened or damaged

For External Use Only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC TOWELETTE

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72976-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72976-006-01	1.6 mL in 1 POUCH; Type 0: Not a Combination Product	10/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/28/2022

Labeler - Ever Ready First Aid (147372960)

Revised: 10/2022

Document Id: ec15d829-8ac1-5d19-e053-2995a90a1c64

Set id: ec15d51e-8a1f-3e5c-e053-2995a90a7774

Version: 1

Effective Time: 20221028