Label: CORALITE MUSCLE AND JOINT PAIN RELIEF- capsacin liquid

  • 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 31, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                                Purpose

    Capsaicin 0.15%............................................................. Topical analgesic

  • PURPOSE

    Uses

    temporarily relieves minor pain of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
  • WARNINGS

    Warnings

    For external use only

    Flammable. Keep away from fire or flame.

    Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.

  • DO NOT USE

    Do not use

    • on wounds or damaged, irritated skin
    • with a heating pad
  • WHEN USING

    When using this product

    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly or cover treated area
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a beath or shower
  • STOP USE

    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 or irritation or rash develops
    • a severe burning sensation occurs

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 18 years of age and older:
    • use only as directed
    • clean and dry affected area
    • place applicator on skin, press firmly and hold to activate the dispensing of liquid
    • massage into painful area until thoroughly absorbed
    • repeat as necessary, but no more than 3 to 4 times daily
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
    • children under 18 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
    • protect from extreme heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, carbomer 940, glycerin, propylene glycol, purified water

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    Cypress, CA 90630 USA

    1-888-645-8204

    Made in China

  • PRINCIPAL DISPLAY PANEL

    90161

  • INGREDIENTS AND APPEARANCE
    CORALITE MUSCLE AND JOINT PAIN RELIEF 
    capsacin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0015 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-161-401 in 1 BOX08/11/2015
    140 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 finalpart34805/08/2015
    Labeler - United Exchange Corp. (840130579)