REFILL 2- benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate 
CMC Group, Inc.

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Refill 2

Drug Facts - Antiseptic Towelettes

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

First Aid Antiseptic

Use:

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warnings:

For external use only.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not use:

In the eyes, or over large areas of the body.

Directions:

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive ingredient:

Purified water.

Drug Facts - Antibiotic Application

Active ingredients (in each gram)

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Use

Warnings

For external use only

Do not use

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

• deep or punture wounds • animal bites • serious burns.

Stop use and ask a doctor if

• the condition persists or gets worse • a rash or other allergic reaction develops.

Keep out of reach of children.

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

Directions

• Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.

Inactive ingredients

Mineral oil, petrolatum, purified water

Antiseptic Towelettes (49687-0016-0) Labeling:

Towelettes

Antibiotic Application (49687-0013-0) Labeling:

Antibiotic Application

Refill 2 (49687-0016-0) Labeling:

Refill 2

REFILL 2 
benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0016
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49687-0016-01 in 1 KIT08/10/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 PATCH 18 g
Part 210 PACKAGE 9 g
Part 1 of 2
ANTISEPTIC TOWELETTES 
benzalkonium chloride cloth
Product Information
Item Code (Source)NDC:49687-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 BOX
1NDC:49687-0011-110 in 1 BOX
10.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00308/10/2016
Part 2 of 2
ANTIBIOTIC APPLICATION 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Item Code (Source)NDC:49687-0013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49687-0013-010 in 1 KIT
10.9 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drugpart33308/10/2016
Labeler - CMC Group, Inc. (117201448)

Revised: 12/2023
Document Id: 0d11ab8e-d438-c7ef-e063-6294a90ae0a3
Set id: 45dde3f0-546c-4ec5-beb0-c3d0432f4983
Version: 7
Effective Time: 20231221
 
CMC Group, Inc.