EQUATE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [WALMART]

EQUATE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [WALMART]
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NDC 49035-847-05
Set ID e08b427f-d070-4521-ad3c-faf295531791
Category HUMAN OTC DRUG LABEL
Packager WalMart
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Neomycin sulfate 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
    Pramoxine hydrochloride 10 mgExternal analgesic
  • Uses

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

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    Not for prolonged use.

    Do not use

    • in the eyes, nose, or over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days
    • a rash or other allergic reaction develops
    • redness, irritation, swelling, or pain persists or increases

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    Adults and children 2 years of age and 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
    • the affected area may be covered with a sterile bandage

    Children under 2 years of age: ask a doctor

  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    cetearyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, purified water

  • Questions or comments?

    1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

    NDC 49035-847-05

    equate™

    Compare
    Neosporin®+
    Pain Relief
    Active
    Ingredients*

    Maximum Strength

    Antibiotic
    Cream
    + Pain Relief

    • Soothes painful cuts, scrapes
      and burns while preventing
      infection

    Neomycin Sulfate
    Polymyxin B Sulfate
    Pramoxine HCl

    First Aid
    Antibiotic
    Pain Relieving
    Cream

    NET WT 0.5 OZ (14g)

    Principal Display Panel - 14 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    EQUATE ANTIBIOTIC PLUS PAIN RELIEF 
    neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-847
    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
    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
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    petrolatum (UNII: 4T6H12BN9U)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-847-051 in 1 CARTON10/18/2018
    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 FINALpart333B10/18/2018
    Labeler - WalMart (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(49035-847)

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