ANCALIMA FIRST AID- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment 
ANCALIMA LIFESCIENCES LIMITED

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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Medpride Triple Antibiotic

Active ingredients

(in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

Purpose

First Aid AntibioticFirst Aid AntibioticFirst 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 ■ over large areas of the body ■ longer than 1 week unless directed by a doctor

Ask a physician before use in case of

■ deep or puncture wounds ■ animal bites ■ serious burns

Stop use and consult 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

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat and humidity

Inactive ingredients

white petrolatum

Package Label

Principal Display & Drug Fact Panel

ANCALIMA  FIRST AID
bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73014-3025
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
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73014-3025-20.5 g in 1 PACKET; Type 0: Not a Combination Product04/08/2019
2NDC:73014-3025-30.9 g in 1 PACKET; Type 0: Not a Combination Product04/08/2019
3NDC:73014-3025-414 g in 1 TUBE; Type 0: Not a Combination Product04/08/2019
4NDC:73014-3025-528.3 g in 1 TUBE; Type 0: Not a Combination Product04/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/08/2019
Labeler - ANCALIMA LIFESCIENCES LIMITED (676760093)

Revised: 1/2021
Document Id: b8b4c69a-ed0d-78b1-e053-2a95a90ade8b
Set id: 860ecb50-9cbb-fe33-e053-2991aa0a744b
Version: 2
Effective Time: 20210112
 
ANCALIMA LIFESCIENCES LIMITED