Label: COOL N HEAT spray

  • NDC Code(s): 13709-311-01
  • Packager: NeilMed Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • ACTIVE INGREDIENT PURPOSE

    Menthol 16% Topical analgesic

  • Uses

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

  • 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.

  • Directions:

    Shake well – adults and children 12 year 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.

  • Inactive ingredients:

    Glycerin, propylene Glycol, SD Alcohol 40 (58%), USP grade purified Water.

  • Dosage and Administration

    Shake well
    adults and children 12 years of age and older spray on affected area not more than 3 to 4 times daily

    children under 12 years of age consult a doctor

  • Indication & Usage

    temporarily relief of pain and itching associated with

    arthritis simple backache muscle strains bruises cramps muscle sprains

  • OTC - Keep Out of Reach of Children

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

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

  • OTC Purpose Section

    temporarily relief of pain and itching associated with:

    arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

  • Cool 'n heat, 16% Menthol/Pain relieving Spray

    Cool and Heat

  • INGREDIENTS AND APPEARANCE
    COOL N HEAT 
    cool n heat spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-311-01118 mL in 1 CAN; Type 0: Not a Combination Product11/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/09/2018
    Labeler - NeilMed Pharmaceuticals, Inc. (799295915)
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