Label: RECTASMOOTHE- lidocaine 5% cream

  • 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 December 23, 2017

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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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