XYRALID (LIDOCAINE 5%) CREAM [INNOVUS PHARMACEUTICALS, INC.]

XYRALID (LIDOCAINE 5%) CREAM [INNOVUS PHARMACEUTICALS, INC.]
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NDC 57483-108-05
Set ID 158c7036-1a48-48c4-960c-cf99a7aa9cb1
Category HUMAN OTC DRUG LABEL
Packager Innovus Pharmaceuticals, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
  • Active ingredient

    Lidocaine 5% w/w

  • Purpose

    Local anesthetic

  • Uses

    Helps relieve 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 and ask a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 day
    • allergic reaction occurs to ingredients in this product
    • symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
    • symtpoms clear up and return within a few days
  • Keep out of 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 thoroughly, Gently dry by patting or blotting wiht toilet tissue or soft cloth before applying.
    • Adults and children 12 years and older: Apply externally to the affected are up to six times a day
    • Children under 12 years of age: Consult a doctor
  • Other information

    Store at 20-25oC (66-77oF) [see USP Controlled Room Temperature].

  • Inactive ingredients

    cetyl alcohol, glyceryl stearate, glyceryl stearate SE, methylparaben, PEG-100 stearate, pertrolatum, propylene glycol, propylparaben, water, white beeswax

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    XYRALID 
    lidocaine 5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-108
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57483-108-0530 in 1 CARTON07/14/2017
    1.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/06/2017
    Labeler - Innovus Pharmaceuticals, Inc. (962507187)
    Registrant - Innovus Pharmaceuticals, Inc. (962507187)

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