Label: EXTRA STRENGTH PAIN RELIEVER- capsaicin and menthol, unspecified form 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 October 30, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Capsaicin 0.035%Topical analgesic
    Menthol 3%Topical analgesic
  • Uses

    temporary relief of minor aches and pains of muscles and joints associated with:

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

    • For external use only.

    When using this product

    • use only as directed
    • do not bandage
    • do not use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • a transient burning sensation may occur upon application but generally disappears in several days.
    • if severe burning sensation occurs, discontinue use
    • do not expose the area treated with product to heat or direct sunlight
    • do not use if you are allergic to capsaicin or chili peppers

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health care 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 over 18 years:

    • apply to affected area
    • massage into painful area until thoroughly absorbed
    • repeat if necessary, but no more than 3 to 4 times daily
    • WASH HANDS WITH SOAP AND WATER AFTER APPLYING
    • children 18 years and younger: ask a doctor
  • Other information

    • store at 20-25° C (68-77° F)
  • Inactive ingredients

    carbomer, ethyl alcohol, germaben II, triethanolamine, water

  • Questions or comments?

    Call us toll free at (877) 514-3132 between 9am and 4pm (PST), Monday through Friday. Visit us on the web at lakotaherbs.com

  • SPL UNCLASSIFIED SECTION

    Manufactured exclusively for
    and distributed by:
    Natural Pain Relief Agency Inc.
    Phoenix, AZ 85086

  • PRINCIPAL DISPLAY PANEL - 57 mL Bottle Box

    LaKOTA®

    SOFT-TOUCH PAIN RELIEVER

    Extra Strength
    Pain Reliever

    Capsaicin and Menthol -
    Topical analgesic

    57mL (2 fl oz)

    PRINCIPAL DISPLAY PANEL - 57 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    capsaicin and menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59092-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin0.35 mg  in 1 mL
    menthol, unspecified form (UNII: L7T10EIP3A) (menthol, unspecified form - UNII:L7T10EIP3A) menthol, unspecified form30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    carbomer interpolymer type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
    alcohol (UNII: 3K9958V90M)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    trolamine (UNII: 9O3K93S3TK)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59092-002-011 in 1 BOX
    157 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34812/01/2014
    Labeler - HPI Health Products Inc. (202932864)
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