Label: NEILMED HOT AND COLD PAIN RELIEF- pain relief spray spray

  • NDC Code(s): 13709-238-01
  • Packager: NeilMed Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • Directions

    Directions: Shake well – adults and children 12 years of age and older: spray product on affected area, not more than 3 to 4 times daily. – children under 12 years of age: consult a doctor.

  • Warnings


    For external use only.
    Flammable: Do not use while smoking or near heat or flames. Avoid long term storage above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
    When using this product avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Use only as directed.
    Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
    If pregnant or breast-feeding, ask a health professional before use.

  • Inactive Ingredients

    Glycerin, Propylene Glycol, SD Alcohol 40 (58%), USP grade Purified Water.

  • Uses

    Temporarily alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains

  • Warnings: Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Drug Facts:

    Topical Analgesic

  • Drug Facts:

    Active Ingredient

    Menthol 16.0%

  • Package Label - NeilMed Hot & Cold Pain Relief

    NeilMed Hot & Cold Pain Relief Spray

  • INGREDIENTS AND APPEARANCE
    NEILMED HOT AND COLD PAIN RELIEF 
    pain relief spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-238
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-238-01118 g in 1 CAN; Type 0: Not a Combination Product11/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/11/2020
    Labeler - NeilMed Pharmaceuticals Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals, Inc799295915manufacture(13709-238)