SOULUS RP RASH AND PAIN (LIDOCAINE HYDROCHLORIDE) CREAM [PURE SOURCE, LLC]

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SOULUS RP RASH AND PAIN (LIDOCAINE HYDROCHLORIDE) CREAM [PURE SOURCE, LLC]
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NDC 65121-100-01
Set ID 5ad3ad36-e814-4707-9f0d-c0be3ad8f166
Category HUMAN OTC DRUG LABEL
Packager Pure Source, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine HCl 0.50%

  • PURPOSE

    Purpose

    Topical Anesthetic

  • INDICATIONS & USAGE

    Uses: For temporary relief of pain and itching associated with minor skin irritations and/or insect bites.

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days, discontinuing use and consult physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, consult physician. Do not bandage tightly.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, contact physician prior to use.

  • DOSAGE & ADMINISTRATION

    Directions: Apply directly to effected area. Do not use more than four times per day.

  • INACTIVE INGREDIENT

    Other Ingredients: Other Ingredients: (Organic) Beeswax, Bentonite, Eugenia Caryophyllus (Clove) Flower Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil, Zinc Oxide, Zingiber Officinale (Ginger) Oil.

  • SPL UNCLASSIFIED SECTION

    Made in USA . Distributed by PURE SOURCE, Inc. Miami, Fl 33172. ph (305) 477-8111

  • PRINCIPAL DISPLAY PANEL

    Soulus Rp

    RASH and PAIN

    Relieves Skin Irritation and Discomfort

    NET WT 1.5oz



    SoulusRp

  • INGREDIENTS AND APPEARANCE
    SOULUS RP RASH AND PAIN 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CLOVE OIL (UNII: 578389D6D0)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-100-0144.36 g in 1 TUBE; Type 0: Not a Combination Product02/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/23/2011
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-100)
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