Label: COCOSKIN- pramoxine cream

  • Category: HUMAN OTC DRUG LABEL

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 April 20, 2016

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  • ACTIVE INGREDIENT

    Pramoxine HCLI 1.00%

  • PURPOSE

    Topical Analgesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age consult a doctor

  • WARNINGS

    For external use only

    Do not use: in around the eyes; more oftehn than directed; longer than 1 week

    When using this product avoid contact with the eyes

    Stop and ask a doctor if: sysmptoms persist for more than 7 days; conditions worsens; symptoms clear up and occur again within a few days

  • INACTIVE INGREDIENT

    Aluminum acetate, aluminum sulfate, water, calcium acetate, cetearyl alcohol, cetearyl olivate, cocos nucifera oil, gluconolactone, glycerin, glyceryl sterate SE, sunflower seed oil, maltodextrin, petrolatum, sodium benzoate, sodium laurylglucosides, hydroxypropylsulfonate, sorbitan olivate, stearic acid, synthetic beeswax.

  • INDICATIONS & USAGE

    For the temporary relief of pain and itching associated with: minor burns, minor cuts, scrapes, minor skin irritations

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    COCOSKIN 
    pramoxine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70678-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1.18 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CALCIUM ACETATE (UNII: Y882YXF34X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM DECYLGLUCOSIDE HYDROXYPROPYLSULFONATE (UNII: B306V77S6R)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALUMINUM ACETATE (UNII: 80EHD8I43D)  
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70678-001-01118 mL in 1 CANISTER; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/01/2016
    Labeler - Net Source, LLC (080118782)
    Registrant - Net Source, LLC (080118782)
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