Label: AMINO RIP MUSCLE PAIN RELIEF- lidocaine hcl liquid

  • NDC Code(s): 54859-415-02
  • Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
  • Category: HUMAN OTC DRUG LABEL

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 October 13, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine HCl

  • PURPOSE

    Purpose

    Topical Anesthetic

  • INDICATIONS & USAGE

    Use Temporarily relieves minor pains

  • WARNINGS

    Warnings For external use only

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor.

    When using this product

    Use only as direct. Read and follow all directions and warnings on this label.

    • Do not allow contact with eyes
    • Do not bandage or apply local heat (such as heating pads) to the area of use.

    Stop use and ask doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • If pregnant or breast feeding, ask a doctor before use.
    • Keep out of the reach of children
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children over 12 years of age
    • Apply generously to the affected area as needed every 6-8 hours, not to exceed 3 applications in a 24 hour period. Not for use in children under 12 years of age
  • INACTIVE INGREDIENT

    Inactive ingredients

    camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water, xantham gum

  • PRINCIPAL DISPLAY PANEL

    musclepain

  • INGREDIENTS AND APPEARANCE
    AMINO RIP MUSCLE PAIN RELIEF 
    lidocaine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-415-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34810/01/2019
    Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
    Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
    Establishment
    NameAddressID/FEIBusiness Operations
    LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION037342305manufacture(54859-415)