DOUBLE ANTIBIOTIC PLUS PAIN RELIEF MAXIMUM STRENGTH- neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream 
Fred's 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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Double Antibiotic + Pain Relief - Freds

Drug Facts


Active ingredients (in each gram)

Neomycin 3.5 mg
Polymyxin B sulfate, USP 10,000 units
Pramoxine hydrochloride, USP 10 mg

Purposes

First aid antibiotic/Pain reliever

Uses

First aid to help prevent infection in and for temporary relief of pain or discomfort due to:

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients

Do not use

  • 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

When using this product

  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and occur again within a few days
  • a rash or other allergic reaction occurs

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:

  • clean 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

Children under 2 years of age: ask a doctor

Other information

  • Store at 59°-86°F (15°-30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

PRINCIPAL DISPLAY PANEL

fred’s Pharmacy

NDC 55315-822-34

RELIEVES PAIN FROM CUTS, SCRAPES & BURNS WHILE PREVENTING INFECTION 

MAXIMUM STRENGTH
DOUBLE ANTIBIOTIC + PAIN RELIEF
(NEOMYCIN SULFATE-POLYMYXIN B SULFATE-PRAMOXINE HCL)

FIRST AID ANTIBIOTIC / PAIN RELIEVING CREAM

NET WT ½ OZ (14g)

Compare To The Active Ingredients In:
*Neosporin® + Pain Relief

carton

double antibiotic

DOUBLE ANTIBIOTIC PLUS PAIN RELIEF  MAXIMUM STRENGTH
neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-822
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
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-822-341 in 1 CARTON05/01/200904/01/2019
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34705/01/200904/01/2019
Labeler - Fred's Inc. (005866116)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 5/2019
Document Id: d61cb26d-67b3-4dcd-abc1-853687ebf2d8
Set id: e7710289-5cad-4448-b7e6-5ca1084043f2
Version: 6
Effective Time: 20190529
 
Fred's Inc.