ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Welly Health PBC

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 (per gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 5000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use:

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

Ask a doctor before use:

  • in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if:

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

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

Directions

Other information

Inactive ingredient

white petrolatum

Principal Display Panel - 0.5g Carton Label

FIRST AID

welly

Bravely Balm

TRIPLE ACTION FIRST AID

ANTIBIOTIC OINTMENT

COUNT 12

NET WT 0.02 oz (0.5g)

TOTAL NET WT 0.21oz (6.0g)

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

Principal Display Panel - 0.5g Carton Label
ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-560
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
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72663-560-1212 in 1 BOX09/06/2019
1NDC:72663-560-340.5 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/06/2019
Labeler - Welly Health PBC (116766884)

Revised: 11/2019
Document Id: 59d3e973-ebc0-44e7-a71d-4dfd539950ee
Set id: 74f12f20-c610-4776-97ba-4c2c6350e102
Version: 2
Effective Time: 20191105
 
Welly Health PBC