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FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF

Dosage form: cream
Ingredients: NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 10000[USP'U] in 1g, PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: FAMILY DOLLAR
NDC Code: 55319-033

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.

Family Wellness Triple Antibiotic Pain Relief Cream 1 oz. 3326 (2018)

Active ingredients (in each gram)                                                                                 Purpose

Neomycin 3.5mg .......................................................................................................First aid antibiotic

Polymyxin B sulfate 10,000 units ................................................................................First aid antibiotic

Pramoxine hydrochloride 10mg ...................................................................................Pain reliever

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns

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

  • 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
  • symptoms persist for more than 1 week or clear up and occur again within a few days
  • rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions Adults and children 2 years and older:

  • clean affected area
  • apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years: ask a doctor

Other information

  • Store between 20 oC and 25 oC (68 oF and 77 oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

cetanol, liquid paraffin, methylparaben, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearic acid

Distributed by:

Midwood Brands, LLC

10811 Monroe Rd.

Matthews, NC 28105

Made in Korea

FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
neomycin sulfate, polymyxin b sulfate, and pramoxine hci cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-033
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITAN MONOSTEARATE 
WATER 
PROPYLPARABEN 
CETYL ALCOHOL 
PARAFFIN 
STEARIC ACID 
METHYLPARABEN 
PETROLATUM 
POLYSORBATE 60 
Packaging
#Item CodePackage Description
1NDC:55319-033-281 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/15/2012
Labeler - FAMILY DOLLAR (024472631)

Revised: 01/2018
 
FAMILY DOLLAR

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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