Label: UP AND UP ANTIBIOTIC PLUS PAIN RELIEF- neomycin, polymyxin b, pramoxine hcl cream

  • NDC Code(s): 11673-313-58, 11673-313-64
  • Packager: Target Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 13, 2019

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  • Active ingredients (in each gram)

    Neomycin sulfate equivalent to 3.5 mg of neomycin base

    Polymyxin B 10,000 units as polymyxin B sulfate

    Pramoxine HCl 10 mg

  • Purpose

    First aid antibiotic

    External analgesic

  • Uses

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

    •
    cuts
    •
    scrape
    •
    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 right away. (1-800-222-1222)

  • Directions

    •
    adults and children 2 years of age or older:
    •
    clean the 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 20°-25°C (68°-77°F)
  • Inactive ingredients

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

  • Questions?

    Call 1-888-547-7400

  • Principal Display Panel

    Compare to active ingredients in Neosporin® + Pain Relief

    maximum strength

    antibiotic cream + pain relief

    first aid antibiotic/pain-relieving cream

    Compare to active ingredients in Neosporin® + Pain Relief

    maximum strength

    antibiotic cream + pain relief

    first aid antibiotic/pain-relieving cream

    #1 doctor recommended combination of active ingredients

    neomycin sulfate/polymyxin B sulfate/pramoxine HCl

    soothing infection protection for burns, cuts and scrapes

    NET WT .5 OZ (14 g)

    Antibiotic Cream + Pain Relief Carton
  • INGREDIENTS AND APPEARANCE
    UP AND UP ANTIBIOTIC PLUS PAIN RELIEF 
    neomycin, polymyxin b, pramoxine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  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)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-313-641 in 1 CARTON04/09/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11673-313-581 in 1 CARTON04/09/2015
    214 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/09/2015
    Labeler - Target Corporation (006961700)
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