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NDC 00924-7116-05 First Aid Only BZK Antiseptic 0.0018 mg/1.35mL Details

First Aid Only BZK Antiseptic 0.0018 mg/1.35mL

First Aid Only BZK Antiseptic 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	00924-7116
Product ID	0924-7116_dbed78da-7f4b-657f-e053-2a95a90ac576
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.0018
Active Ingredient Units	mg/1.35mL
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 00924-7116-05 (00924711605)

Pricing Information	N/A
NDC Package Code	0924-7116-05
Billing NDC	00924711605
Package	200 PACKET in 1 BOX (0924-7116-05) / 1.35 mL in 1 PACKET
Marketing Start Date	2022-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dbed7ed6-a9b8-7b59-e053-2a95a90ac0cb Details

Drug Facts Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

First Aid antiseptic to help prevent infection in minor

•cuts

•scrapes

•burns

Warnings

For External Use Only.

Do not use

•in the eyes

•over large areas of the body

•longer than 1 week

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have •Deep or puncture wounds •Animal bites •Serious burns

Stop use

Stop use and ask doctor if the condition persists or gets worse.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

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

Directions

•Clean affected area

•Apply 1 to 3 times daily

•May be covered with a sterile bandage, once area dries

Inactive Ingredients

methylchloroisothiazolinone/methylisothiazolinone mixture, water

SPL UNCLASSIFIED SECTION

Questions 1.800.835.2263

PRINCIPAL DISPLAY PANEL

Box Label

INGREDIENTS AND APPEARANCE

FIRST AID ONLY BZK ANTISEPTIC

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-7116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0018 mg in 1.35 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-7116-00	1.35 mL in 1 PACKET; Type 0: Not a Combination Product	04/15/2022
2	NDC:0924-7116-04	100 in 1 BOX	04/15/2022
2		1.35 mL in 1 PACKET; Type 0: Not a Combination Product
3	NDC:0924-7116-05	200 in 1 BOX	04/15/2022
3		1.35 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC:0924-7116-03	50 in 1 BOX	04/15/2022
4		1.35 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC:0924-7116-01	10 in 1 BOX	04/15/2022
5		1.35 mL in 1 PACKET; Type 0: Not a Combination Product
6	NDC:0924-7116-02	20 in 1 BOX	04/15/2022
6		1.35 mL in 1 PACKET; 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	04/15/2022

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	label(0924-7116) , pack(0924-7116)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	label(0924-7116) , pack(0924-7116)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		117825595	manufacture(0924-7116)

Revised: 4/2022

Document Id: dbed78da-7f4b-657f-e053-2a95a90ac576

Set id: dbed7ed6-a9b8-7b59-e053-2a95a90ac0cb

Version: 1

Effective Time: 20220405

Search by Drug Name or NDC

NDC 00924-7116-05 First Aid Only BZK Antiseptic 0.0018 mg/1.35mL Details

First Aid Only BZK Antiseptic 0.0018 mg/1.35mL

Product Information

Package

Package Images

NDC 00924-7116-05 (00924711605)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dbed7ed6-a9b8-7b59-e053-2a95a90ac0cb Details

Drug Facts Active Ingredient

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

Stop use

SPL UNCLASSIFIED SECTION

Directions

Inactive Ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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