CARE ONE MAXIMUM STRENGTH FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HYDROCHLORIDE) CREAM [FOODHOLD U.S.A. LLC]

CARE ONE MAXIMUM STRENGTH FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HYDROCHLORIDE) CREAM [FOODHOLD U.S.A. LLC]
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NDC 41520-315-14
Set ID 8e1eae9a-e7f8-49a0-b877-fe1a4f7bfdf8
Category HUMAN OTC DRUG LABEL
Packager Foodhold U.S.A. LLC
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredients (in each gram) Purpose

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

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

    Pramoxine HCl10 mg.................................................................. External analgesic

  • PURPOSE

    Uses

    • first aid to help prevent infection and for the temporary relief of pain in minor
    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes or nose
    • over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • rash or allergic reaction develops
    • symptoms persist for more than 1 week or clear up and come back within a few days
    • condition persists or gets worse
    • redness, irritation, swelling, or pain persists or increases
  • PREGNANCY OR BREAST FEEDING

    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

  • INDICATIONS & USAGE

    Directions

    Adult and children 2 years of age and older

    • clean affected area
    • apply a small amount (equal to surface area of the tip of the finger) on area 1 to 3 times daily
    • may be covered with a sterile bandage
    • Children under 2 years: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    cetyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearic acid

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY

    FOODHOLD, U.S.A., LLC

    LANDOVER, MD 20785

    MADE IN SOUTH KOREA

  • PRINCIPAL DISPLAY PANEL

    31462

  • INGREDIENTS AND APPEARANCE
    CARE ONE MAXIMUM STRENGTH FIRST AID ANTIBIOTIC 
    neomycin sulfate polymyxin b sulfate pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-315
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-315-141 in 1 BOX02/02/2019
    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 finalpart333B09/08/2014
    Labeler - Foodhold U.S.A. LLC (809183973)

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