MAKESENSE FIRST AID- bacitracin zinc neomycin polymyxin b sulfate ointment 
Cherry Hill Sales Co

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B sulfate 5000U

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Uses

first aid to help prevent infection in:  ■ minor cuts ■ scrapes ■ burns

Warnings

For external use only

Do not use

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

Ask a doctor before use

■ on deep puncture wounds, animal bites, or serious burns

Stop use and consult a doctor if

■ the condition persists worsens ■ 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 and dry thoroughly ■ 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

Other Information

■ store at room temperature 68 to 77F (20to 25C) ■ see carton or tube crimp for lot number and expiration date

Inactive ingredients

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

Package Label

Package Label

MAKESENSE  FIRST AID
bacitracin zinc neomycin polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  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 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
CERESIN (UNII: Q1LS2UJO3A)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69020-202-1414 g in 1 TUBE; Type 0: Not a Combination Product06/15/2014
2NDC:69020-202-099.3 g in 1 TUBE; Type 0: Not a Combination Product06/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/15/2014
Labeler - Cherry Hill Sales Co (145959768)

Revised: 8/2016
Document Id: 3995a4be-fb88-32b4-e054-00144ff8d46c
Set id: dfefde48-99ca-4443-b0bc-73e6c095210e
Version: 3
Effective Time: 20160808
 
Cherry Hill Sales Co