Label: EARTHS CARE ARTHRITIS- capsaicin cream

  • NDC Code(s): 24286-1559-2
  • Packager: DLC Laboratories, Inc.
  • 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 November 13, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Capsaicin 0.1%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain of muscles and joints associated with:

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

    For external use only

    When using this product

    • read leaflet inside carton before use
    • use only as directed
    • do not bandage tightly or cover treated area
    • do not use with a heating pad or other heat sources
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • a temporary burning sensation may occur upon application but normally disappears within several days
    • if a severe burning sensation occurs, stop use immediately and read important information on leaflet inside carton
    • do not expose the area treated with product to heat or direct sunlight
    • do not apply immediately before or after activities such as bathing, swimming, sunbathing or strenuous exercise

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding, 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 over 18 years:

    • apply to affected area
    • massage into painful area until thoroughly absorbed
    • repeat as necessary, but no more than 3 or 4 times daily
    • WASH HANDS WITH SOAP AND COLD WATER AFTER APPLYING

    Children 18 years or younger: ask a doctor

  • Inactive ingredients

    beeswax, Butyrospermum parkii (shea) butter, cetearyl glucoside, cetyl alcohol, citric acid, glycerin, glyceryl stearate, heptyl undecylenate, hydrogenated castor oil, Oryza sativa (rice) bran extract, phenoxyethanol, potassium sorbate, Prunus amygdalus dulcis (sweet almond) oil, purified water, sodium stearoyl glutamate, sodium stearoyl lactylate, stearic acid, xanthan gum

  • Questions

    1-888-602-6380

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Earth's Care Natural Products, Inc.
    Long Beach, California 90805 USA

  • PRINCIPAL DISPLAY PANEL - 68 g Tube Box

    Odor-Free

    EARTH'S
    CARE    ™

    NON-GREASY
    FORMULA

    Arthritis
    Cream

    High Potency

    Capsaicin 0.1%
    Penetrating relief for
    joint and muscle pain

    with Natural Rice Bran
    and Almond Oil

    External Analgesic

    1%
    FOR THE
    PLANET    ℠
    MEMBER

    2.4 OZ. (68 g)

    PRINCIPAL DISPLAY PANEL - 68 g Tube Box
  • INGREDIENTS AND APPEARANCE
    EARTHS CARE ARTHRITIS 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1559
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1559-21 in 1 BOX09/25/2013
    168 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34809/25/2013
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1559) , LABEL(24286-1559)
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