CVS PHARMACY (BENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDE) SPRAY [HEALTH-TECH, INC.]

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CVS PHARMACY (BENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDE) SPRAY [HEALTH-TECH, INC.]
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NDC 48871-000-00
Set ID 60cc1ea1-f063-4988-bfe9-d18cfe323d92
Category HUMAN OTC DRUG LABEL
Packager Health-Tech, Inc.
Generic Name
Product Class
Product Number
Application Number PART310.545
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  • Active Ingredients

    Benzalkonium Chloride

    Pramoxine Hydrochloride

  • Purpose

    First Aid Antispetic

    Topical Analgesic

  • Uses

    First aid to help prevent infection and temporarily relieve pain or discomfort in minor cuts, scrapes and burns.

  • Warnings

    For external use only.
  • Do not use

    Do not use
    • in the eyes
    • overlarge 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:

    • condition or symptoms get worse or last more than one week
    • symptoms clear up and occur again within a few days
  • 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 the affected area
    • spray a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
    Children under 2 years of age: consult a doctor
  • Other information

    Store at 200 to 250 C (680 to 770 F) Prior to initial use, prime pump by depressing multiple times.

  • Inactive Ingredients:

    DI Water, Edetate Disodium, Propylene Glycol

  • PRINCIPAL DISPLAY PANEL

    MM1bottle label jpeg

  • PRINCIPAL DISPLAY PANEL

    MM3master shipping carton

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY 
    benzalkonium chloride, pramoxine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride.195 mL  in 15 mL
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride.15 mL  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Edetate Disodium (UNII: 7FLD91C86K)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48871-000-0012 in 1 BOX
    16 in 1 CARTON
    11 in 1 BLISTER PACK
    115 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart310.54501/19/2010
    Labeler - Health-Tech, Inc. (084007889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health-Tech, Inc.084007889manufacture
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