TEETER RENEW MUSCLES PAIN RELIEVING (METHYL SALICYLATE, MENTHOL) CREAM [STL INTERNATIONAL INC]

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TEETER RENEW MUSCLES PAIN RELIEVING (METHYL SALICYLATE, MENTHOL) CREAM [STL INTERNATIONAL INC]
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NDC 70329-730-01
Set ID b90dc5b9-c31d-4770-a291-98d036ae8723
Category HUMAN OTC DRUG LABEL
Packager STL International INC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredients

    Methyl Salicylate 10.0%

    Menthol 7.0%

    Purpose

    Topical Analgesic

  • Uses

    Temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache • arthritis • strains • bruises • sprains

  • Warnings

    For external use only.

    Allergy Alert:

    If you had prior allergic reaction to aspirin or salicylate, please consult a doctor before use.

    Do not use

    • on wounds or damaged skin • with a heating pad

    Ask a physician before use if you have

    redness over the affected area.

    When using this product

    • avoid contact with eyes and mucus membranes • do not bandage tightly

    Stop use and ask a physician if

    • condition worsens or symptoms persist for more than 7 days

    • symptoms clear up and occur again within a few days

    • excessive skin irritation occurs

    • pregnant or breastfeeding

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    Use only as directed

    • Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: consult a physician

  • Other information

    • Store at 20° to 25°C (68°-77°F)

  • Inactive Ingredients

    Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, C13-14 isoparaffin, cetyl alcohol, citrus aurantium dulcis (orange) peel oil, chondroitin sulfate, dimethyl sulfone (MSM), emu oil, ethoxydiglycol, gluconolactone, glucosamine sulfate, glycerin, glyceryl stearate, isopropyl myristate, laureth-7, PEG-100 stearate, polyacrylamide, polysorbate-20, sodium benzoate, stearic acid.

  • Package Labeling

    Label2

  • INGREDIENTS AND APPEARANCE
    TEETER RENEW MUSCLES PAIN RELIEVING 
    methyl salicylate, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70329-730
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EMU OIL (UNII: 344821WD61)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70329-730-011 in 1 BOX02/09/2017
    15 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/12/2016
    Labeler - STL International INC (062729769)
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