Label: EASE YOUR PAIN- menthol cream

  • NDC Code(s): 72683-002-01
  • Packager: Proximity Capital Partners LLC dba Asutra
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 7, 2020

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  • ACTIVE INGREDIENT

    Menthol USP 4%

  • PURPOSE

    Menthol USP 4% ........................... Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Use only as directed.

    For external use only. Keep away from excessive heat or flame.

    When using this product:

    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments

    Stop use and ask doctor if:

    • Condition worsens
    • Symptoms persist for more than 7 days, or clear up and occur again within a few days

    If pregnant or breastfeeding: Ask a health professional before using.

    Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older:

    • Apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age:

    • Consult physician.
  • STORAGE AND HANDLING

    • Store in a cool, dry place.
    • Avoid direct sunlight.
    • Tamper-evident for your protection. Use only if safety seal is intact.
    • Keep away from excessive heat or flame.
  • INACTIVE INGREDIENT

    Purified Water, Ethyl Alcohol, Dimethyl Sulfone (MSM), Arnica Montana, Calendula Officinalis Flower Extract, Methyl Glucose Dioleate, Sodium Hydroxide, Baobab Oil, Carbomer, Citric Acid

  • QUESTIONS

    888-819-6472

    Monday - Friday, 9am - 5pm CT

    Report any serious side effects to number above.

  • PRINCIPAL DISPLAY PANEL

    001

  • INGREDIENTS AND APPEARANCE
    EASE YOUR PAIN 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72683-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72683-002-011 in 1 CARTON01/21/2019
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/21/2019
    Labeler - Proximity Capital Partners LLC dba Asutra (081214985)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioLyte Laboratories, LLC015560564manufacture(72683-002)
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