ECOLYPTUS PAIN RELIEVING MUSCLE RUB (MENTHOL) CREAM [PURE SOURCE, LLC]

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ECOLYPTUS PAIN RELIEVING MUSCLE RUB (MENTHOL) CREAM [PURE SOURCE, LLC]
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NDC 65121-715-88
Set ID 2ac95778-c7c0-44a2-b906-8783a0525e47
Category HUMAN OTC DRUG LABEL
Packager Pure Source, LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • ecolyptus pain relieving muscle rub


  • Active Ingredients

    Menthol 6.0%

    Purpose

    External Analgesic

  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with:

    • arthritis
    • backache
    • strains
    • sprains
  • Warnings

    For external use only.

    Do Not:

    • Get into eyes or mucous membranes
    • Apply to wounds or damaged skin
    • Bandage

    Stop use and consult a physician if:

    Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions:

    For adults and children 2 years and older: Apply to affected area up to 4 times daily. For children under 2 years of age: Consult a physician.

  • Inactive Ingredients:

    Aqua [Deionized Water], Caprylic/Capric Triglyceride, Cetearyl Olivate, Citric Acid, Eucalyptus Globulus Oil, Gluconolactone, Glycerin, Potassium Sorbate, SD-Alcohol 38B, Sodium Benzoate, Sorbitan Olivate, Xanthan Gum

  • ecolyptus pain relieving muscle rub 88.7ml (65121-715-88)

    EcoLyptus Label

  • INGREDIENTS AND APPEARANCE
    ECOLYPTUS PAIN RELIEVING MUSCLE RUB 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-715
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-715-881 in 1 CARTON02/09/2017
    188.7 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/06/2014
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-715) , repack(65121-715)
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