Label: CVS PHARMACY- benzalkonium chloride, pramoxine hydrochloride spray

  • 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 January 26, 2010

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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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