BACITRAYCIN PLUS (BACITRACIN ZINC AND PRAMOXINE HYDROCHLORIDE) OINTMENT [FIRST AID RESEARCH CORP]

BACITRAYCIN PLUS (BACITRACIN ZINC AND PRAMOXINE HYDROCHLORIDE) OINTMENT [FIRST AID RESEARCH CORP]
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NDC 75983-056-01, 75983-056-02
Set ID 7f232729-a442-fd8b-e053-2991aa0adf9e
Category HUMAN OTC DRUG LABEL
Packager First Aid Research Corp
Generic Name
Product Class
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredients (in each gram) Purposes

    Bacitracin zinc 500 units............First aid antibiotic

    Parmoxine HCl 10 mg...............External analgesic

  • PURPOSE

    Uses

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

    For external use only

  • DO NOT USE

    Do no use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body or bandage
  • 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
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • condition persists or gets worse
    • redness, irritation, swelling, or pain persists or increases
    • rash or other allergic reactin develops
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    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
    • children under 2 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients aloe vera oil, petrolatum

  • DOSAGE & ADMINISTRATION

    Dirtributed by:

    FIRST AID RESEARCH CORP.

    Jupiter, FL 33478 Made in China

  • PRINCIPAL DISPLAY PANEL

    cartoncarton

  • INGREDIENTS AND APPEARANCE
    BACITRAYCIN PLUS 
    bacitracin zinc and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75983-056-011 in 1 BOX01/09/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:75983-056-021 in 1 BOX01/09/2019
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/09/2019
    Labeler - First Aid Research Corp (089405927)

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