FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hci cream 
FAMILY DOLLAR

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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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:

Warnings

For external use only

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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:

Children under 2 years: ask a doctor

Other information

Inactive ingredients

cetanol, methylparaben, mineral oil, 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

3326

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PARAFFIN (UNII: I9O0E3H2ZE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-033-281 in 1 CARTON10/15/2012
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/15/2012
Labeler - FAMILY DOLLAR (024472631)

Revised: 1/2019
Document Id: 80c68765-ae5a-d554-e053-2a91aa0a966f
Set id: 9f0313a2-3e80-4b93-8362-3e5ea55b29e7
Version: 5
Effective Time: 20190131
 
FAMILY DOLLAR