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NDC 00924-7115-04 First Aid Only BZK Antiseptic Towelettes 1.3 mg/mL Details

First Aid Only BZK Antiseptic Towelettes 1.3 mg/mL

First Aid Only BZK Antiseptic Towelettes is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Acme United Corporation. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	00924-7115
Product ID	0924-7115_c927f845-1384-ae85-e053-2995a90a12fc
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	First Aid Only BZK Antiseptic Towelettes
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Acme United Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00924-7115-04 (00924711504)

Pricing Information	N/A
NDC Package Code	0924-7115-04
Billing NDC	00924711504
Package	100 POUCH in 1 CARTON (0924-7115-04) / 1.6 mL in 1 POUCH
Marketing Start Date	2021-08-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c927f845-1383-ae85-e053-2995a90a12fc Details

Drug Facts

Active ingredient

Benzalkonium Chloride 0.133%

Purpose

First Aid Antiseptic

Uses

Antiseptic cleansing of face, hands, and body without soap and water. Air dries in seconds.

Warnings

Do not use

in the eyes
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

Tear open packet, unfold, and use as a washcloth.

Inactive ingredients

Purified Water, sodium bicarbonate

Questions

1-800-835-2263

PRINCIPAL DISPLAY PANEL

carton label

INGREDIENTS AND APPEARANCE

FIRST AID ONLY BZK ANTISEPTIC TOWELETTES

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-7115(NDC:59050-331)
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)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-7115-00	1.6 mL in 1 POUCH; Type 0: Not a Combination Product	08/09/2021
2	NDC:0924-7115-01	10 in 1 CARTON	08/09/2021
2		1.6 mL in 1 POUCH; Type 0: Not a Combination Product
3	NDC:0924-7115-02	25 in 1 CARTON	08/09/2021
3		1.6 mL in 1 POUCH; Type 0: Not a Combination Product
4	NDC:0924-7115-03	50 in 1 CARTON	08/09/2021
4		1.6 mL in 1 POUCH; Type 0: Not a Combination Product
5	NDC:0924-7115-04	100 in 1 CARTON	08/09/2021
5		1.6 mL 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	part333E	08/09/2021

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-7115) , repack(0924-7115)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-7115) , repack(0924-7115)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		117825595	relabel(0924-7115) , repack(0924-7115)

Revised: 8/2021

Document Id: c927f845-1384-ae85-e053-2995a90a12fc

Set id: c927f845-1383-ae85-e053-2995a90a12fc

Version: 1

Effective Time: 20210809