RECTASMOOTHE (LIDOCAINE 5%) CREAM [LEADING PHARMA, LLC]

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RECTASMOOTHE (LIDOCAINE 5%) CREAM [LEADING PHARMA, LLC]
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NDC 69315-301-30
Set ID 78120481-b780-4e41-885d-11e424d1f717
Category HUMAN OTC DRUG LABEL
Packager Leading Pharma, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
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  • Active Ingredient


    Lidocaine 5% w/w

  • Purpose

    Local anesthetic

  • Uses

    Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

  • WARNINGS:

    For external use only.

    When using this product

    • avoid contact with the eyes
    • do not exceed recommended dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any other mechanical device or applicator

    Stop use and ask doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs to ingredients in this product
    • symptom being treated does not suside or if redness, irritation swelling, pain or other symptoms develop or increase
    • symptoms clear up and return within a few days

    Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • When practical, clean area with mild soap and warm water and rinse thouroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
    • Adults and children 12 years and older: Apply externally to the affected area up to six times a day.
    • Children under 12 years of age: Consult a doctor
    • To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.
  • Other Information

    Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

  • Inactive Ingredients

    cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax

  • Lidocaine 5%

    Label
    Carton
  • INGREDIENTS AND APPEARANCE
    RECTASMOOTHE 
    lidocaine 5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69315-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69315-301-301 in 1 CARTON05/15/2016
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/01/2011
    Labeler - Leading Pharma, LLC (079575060)
    Registrant - Leading Pharma, LLC (079575060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lyne Laboratories, Inc.053510459MANUFACTURE(69315-301)
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