DYNAMICLEAR ORO (CAMPHOR (NATURAL)) SWAB [DYNAMICLEAR PARTNERS LLC]

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DYNAMICLEAR ORO (CAMPHOR (NATURAL)) SWAB [DYNAMICLEAR PARTNERS LLC]
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NDC 70955-886-01
Set ID 46688e9b-5473-4bda-bcf8-dad206a39d0d
Category HUMAN OTC DRUG LABEL
Packager Dynamiclear Partners LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Camphor 3%

  • Purpose

    Fever Blister/

    Cold Sore Treatment

    External Analgesic

  • Uses

    Pain Relief

    Relieves Burning and Itching

    Fever Blister/Cold Sore Relief

  • Warnings

    For External Use Only

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Ask a doctor or pharmacist before use if you have any questions about this product

    When using this product

    Do not get into eyes

    Stop use and ask a doctor if

    condition worsens

    symptoms last more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding ask a health professional before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact poison control center right away.

  • Directions

     Adults and Children

    12 years and older

    		 Single Application

     Children under 12

     Use under adult

    supervision only

     Children under 2

    years

     Do not use consult

    a physician

    Apply a single application to each outbreak as needed.

    Repeat application may not be necessary.  If symptoms

    persist over 24hr apply another single application.

  • Other Information:

    A slight sting may be felt when applying at blistered stage.

    When applying to active blisters the scab occasionally turns dark before falling off within a few days.

    Store at 15-30C (59-86F) Away from Heat & Direct Sunlight.

  • Inactive Ingredients:

    glycerol, isopropyl alcohol, polyethylene glycol, cupric sulfate, polysorbate, vitamin e, calendula officinalis, hypericum perforatum, aloe vera

  • SPL UNCLASSIFIED SECTION

    Questions:  Dynamiclear Partners LLC.

    www.dynamiclear-oro.com

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DYNAMICLEAR ORO 
    camphor (natural) swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70955-886
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70955-886-010.5 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product09/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/05/2016
    Labeler - Dynamiclear Partners LLC (080180754)
    Establishment
    NameAddressID/FEIBusiness Operations
    ACTIV PHARMACEUTICALS PTY LTD755111275analysis(70955-886) , manufacture(70955-886) , label(70955-886) , pack(70955-886)
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