Label: PR- menthol lotion

  • NDC Code(s): 72358-101-03, 72358-101-04
  • Packager: Amphp, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • ACTIVE INGREDIENT

    Menthol 0.5%

  • PURPOSE

    Pain relieving sports lotion

  • INDICATIONS & USAGE

    For the temporary relief of pain

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use if allergic to any ingredient in this product or sensitive to sodium

  • WHEN USING

    Use only as directed. Avoid contact with eyes.

  • STOP USE

    Stop use and ask doctor if:

    Symptoms persist for more than 7 days

    Symptoms 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

    Shake well. 15 minutes to 2 hours before your workout, apply generously to the muscles you use most (30 minutes before water sports). Completely cover each muscle, a palmful per use. Reapply after for added recovery. Wash hands.

    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 doctor

  • OTHER SAFETY INFORMATION

    Store at 20-25C (68-77F)

  • INACTIVE INGREDIENT

    sodium bicarbonate, water, isopropyl palmitate, lecithin, poloxamer 407, alcohol denat., benzyl alcohol, polygylceryl-4 laurate, hydrated silica, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) seed oil, caprylic/capric triglyceride, sodium hydroxide, fragrance

  • PR Lotion 300 gram tube principal display panel

    Standard Tube

  • PR Lotion 20 gram packet principal display panel

    On-The-Go Packet

  • PR Lotion 100 gram tube principal display panel

    Travel Tube

  • INGREDIENTS AND APPEARANCE
    PR 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72358-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72358-101-04300 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2018
    2NDC:72358-101-0320 g in 1 PACKET; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2018
    Labeler - Amphp, Inc (081138140)
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