Label: ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING CREAM- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 17, 2020

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  • Active Ingredients

    Menthol 1.25%

  • Purpose

    Topical Analgesic

  • Indications:

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Provides penetrating pain relief.

  • WARNINGS

    For external use only.

    • Avoid contact with the eyes

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

    Do not apply to wounds or damaged skin. Do not bandage tightly.

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

  • Directions

    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 a doctor.

  • INACTIVE INGREDIENT

    Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Propylene Glycol, Glycerin, Glyceryl Stearate, Acrylamide Sodium Acrylate Copolymer, Arnica Montana Flower Extract, Cetyl Alcohol, PEG-100 Stearate, Mineral Oil, Ethoxydiglycol, Boswellia Serrata Extract, Dimethicone, Butyrospermum Parkii (Shea Butter), Fragrance (Parfum), Diazolidinyl Urea, Methylparaben, Trideceth-6, Disodium EDTA, Propylparaben, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Glycyrrhiza Glabra (Licorice) Root Extract, Dimethyl Sulfone, Choline Bitartrate, Pyridoxine, Glucosamine Sulfate, Camphor, Cetyl Myristoleate, Triethanolamine

  • Questions or Comments?

    Worldwide Cosmetics, Inc.

  • Eternal Spirit Beauty Painless Pain Relieving Cream

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    ETERNAL SPIRIT BEAUTY  PAINLESS PAIN RELIEVING CREAM
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PYRIDOXINE (UNII: KV2JZ1BI6Z)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LICORICE (UNII: 61ZBX54883)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0223-3118 mL in 1 JAR; Type 0: Not a Combination Product01/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/29/2016
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0223) , manufacture(58443-0223) , label(58443-0223) , analysis(58443-0223)
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