ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment 
Kareway Product, Inc.

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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Soundbody Antibiotic Plus

Active Ingredients (in each gram)

Bacitracin Zinc 500units

Neomycin 3.5mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Purpose

Active ingredients

(each gram contains)
Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine HCI 10 mgExternal analgesic

Uses

First aid to help prevent infection and provide temporary relief of pain or discomfort in minor

Warnings

For external use only

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • condition persists for more than 1 week, or clear up and occur again within a few days
  • 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

adults and children 2 years of age and older:

children under 2 years of age: consult a physician

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

petrolatum

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment + Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic Ointment

Maximum Strength

NET WT 1 oz (28.3 g)

carton

ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0682
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0682-11 in 1 CARTON02/17/2020
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/17/2020
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2023
Document Id: f4eb647a-12ca-c5db-e053-2995a90ac625
Set id: 9ee44797-8673-faef-e053-2a95a90a3b0c
Version: 2
Effective Time: 20230217
 
Kareway Product, Inc.