Label: SPORTS PAIN RELIEF BALM- menthol 4% cream

  • 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 March 17, 2021

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  • Active ingredient

    Menthol 4%

  • Purpose

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

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask doctor if

    • condition worsens
    • irritation occurs
    • 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 use.

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

  • Directions

    Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    Children under 12 years of age: consult a doctor.

  • Other information

    • Store in a cool dry place away from light
  • Inactive ingredients

    organic shea (butyrospermum parkii) butter, organic carnauba (copernicia cerifera) wax, peppermint (mentha piperita) leaf oil, organic sunflower (helianthus annuus) seed oil, organic jojoba (simmondsia chinensis) seed oil, organic coconut (cocos nucifera) oil, cetearyl olivate, sorbitan olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, pepper (capsicum annuum) fruit extract, organic turmeric (cucuma longa) root oil, water (aqua), glycerin, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, organic rosemary (rosmarinus officinalis) leaf oil, organic eucalyptus (eucalyptus globulus) leaf oil, magnesium sulfate

  • QUESTIONS

    Manufactured for HempFusion

    3820 NW 14th Street Suite A & B

    Topeka, KS 66618

    877.NOW.HEMP (877.669.4367)

    hempfusion.com

  • Principal Display Panel

    Sports Pain

    Relief

    BALM

    HempFusion

    Menthol 4%

    Including Capsicum, hemp extract with naturally occuring CBD (80mg/jar) + Terpenes (75mg/jar) from black pepper and clove & other natural skin moisturizers

    U.S. HEMP AUTHORITY H CERTIFIED

    NON-GMO

    ALL SKIN TYPES

    1.4 oz (40g)

    BoxLabel

  • INGREDIENTS AND APPEARANCE
    SPORTS PAIN RELIEF BALM 
    menthol 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-986
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    HEMP (UNII: TD1MUT01Q7)  
    PAPRIKA (UNII: X72Z47861V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    CLOVE OIL (UNII: 578389D6D0)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73672-986-401 in 1 CARTON02/10/2020
    140 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2020
    Labeler - HEMPFUSION, INC. (117152485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc. (DBA Paklab) 177711082manufacture(73672-986)
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