EASE YOUR PAIN (MENTHOL) CREAM [PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA]

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EASE YOUR PAIN (MENTHOL) CREAM [PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA]
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NDC 72683-002-01
Set ID 83366ae1-e1d9-2a30-e053-2a91aa0a1cc4
Category HUMAN OTC DRUG LABEL
Packager Proximity Capital Partners LLC dba Asutra
Generic Name
Product Class
Product Number
Application Number PART348
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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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