TRUE PAIN RELIEF PLUS (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [NATURE CITY, LLC]

TRUE PAIN RELIEF PLUS (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [NATURE CITY, LLC]
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NDC 69180-001-02
Set ID 56d9b063-6beb-47c4-abd2-e968b8c74141
Category HUMAN OTC DRUG LABEL
Packager Nature City, LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients:

    Methyl Salicylate 10.00% w/w

    Menthol  1.25% w/w

    Capsaicin  0.025% w/w

  • Purpose

    Topical analgesic

  • Uses:

    Temporarily relief of minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises

  • Warnings:

    For external use only

    When using this product • use only as directed · do not bandage tightly or use with a heating pad  • do not apply to wounds or damaged skin

    ​Avoid contact with eyes and mucous membranes

  • DO NOT USE

    ​Stop use and ask doctor if • condition worsens • if symptoms persists for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops.​​

  • PREGNANCY OR BREAST FEEDING

    ​If pregnant or breast-feeding​, ask a health care provider before use.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions:

    Adults and children over 12 years • apply generousely to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 times daily • wash hands with soap and water after use

    Children 12 years or younger: consult a doctor.

  • Inactive Ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Camphor, Caprylyl Glycol, Cetyl Alcohol, Disodium EDTA, Isopropyl Myristate, Methylisothiazolinone, PEG-8, Triethanolamine, Water

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    TRUE PAIN RELIEF PLUS 
    methyl salicylate, menthol, capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69180-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69180-001-0259 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2003
    Labeler - Nature City, LLC (026617122)

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