Label: 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 (burtyrospermum parkii) butter, organic carnauba (copernicia cerifera) wax, peppermint leaf oil (mentha piperita), 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, black pepper (piper nigrum) fruit oil (source of terpenes), clove (syzygium aromaticum) flower oil, magnesium sulfate, rosemary (rosmarinus officinalis) extract

  • 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

    Pain

    Relief

    BALM

    HempFusion

    Menthol 4%

    Including hemp extract with naturally occurring CBD (50mg/jar) + Terpenes (45mg/jar) from black pepper and clove & other nautral skin moisturizers

    NON-GMO

    ALL SKIN TYPES

    1.4 oz (40g)

    BoxLabel

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF BALM 
    menthol 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-988
    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
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ROSEMARY (UNII: IJ67X351P9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HEMP (UNII: TD1MUT01Q7)  
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73672-988-401 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(73672-988)
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