ODYNIA-U (LIDOCAINE, CAPSICUM) PATCH [URSH PHARMACEUTICAL INC.]

ODYNIA-U (LIDOCAINE, CAPSICUM) PATCH [URSH PHARMACEUTICAL INC.]
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NDC 69647-003-01
Set ID ee8d953d-ecc4-4013-8227-fa18e6d6d24f
Category HUMAN OTC DRUG LABEL
Packager Ursh Pharmaceutical Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine 4 %

    Capsicum 0.03 %


  • PURPOSE

    Purpose

    Topical Analgesic

    External Analgesic

  • INDICATIONS & USAGE

    Uses temporarily relieves minor aches and pains associated with:  -arthritis  -simple backache --bursitis  --tendonitis

    --muscle strains --sprains  --bruises  --cramps

  • WARNINGS

    Warnings

    For external use only

    When using this product -use only as directed  -do not bandage tightly or use with a heating pad

    -avoid contact with eyes and mucus membranes  -do not apply to wounds or damaged, broken or irritated skin

  • STOP USE

    Stop use and ask a doctor if  -condition worsens  -redness is present  -irritation develops

    -symptoms persist for more than 7 days or clear up and occur again within a few days

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children over 12 years:

    -remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

    -carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

    -once exposed portion of patch is positioned, carefully remove remaining backing to completely

    apply patch to affected area

    -wear one Icy Hot Patch up to 8 hours

    -repeat as necessary, but no more than 3 times daily

    children under 12 years or younger:  ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients  aluminum hydroxide, carmellose sodium, glycerin, isopropyl myristate, methyl

    acrylate / 2 -ethylhexyl acrylate copolymer, nonoxynol-30, polyacryic acid, polysorbate 80, sodium polyacrylate, sorbitan

    sesquioleate, starch / acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ODYNIA-U  
    lidocaine, capsicum patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69647-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM.03 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    SODIUM (UNII: 9NEZ333N27)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69647-003-0115 in 1 BOX
    110 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/12/2015
    Labeler - Ursh Pharmaceutical Inc. (079715344)

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