Label: CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE KNEE- menthol patch

  • 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

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  • ACTIVE INGREDIENT

    Active ingredient                                                                      Purpose

    Menthol 16.0%..................................................Topical Analgesic Patch

  • PURPOSE

    Uses

    • temporarily relieves minor aches and pains of muscles and joints associated with:
    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • on a child under 12 years of age with arthritis-like-conditions
  • ASK DOCTOR

    Ask a doctor before use if you have

    • redness over the affected area
  • WHEN USING

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly over sleeve or use with a heating pad
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • redness is present or irritation or rash develops
  • 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 12 years of age and older:
    • open pouch and remove sleeve
    • remove plastic insert and discard
    • pull sleeve onto knee, large ankles or elbows until the colored (medicated) section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings should help you understand how to do this.
    • apply one sleeve to affected area no more than 3 times daily
    • do not wear sleeve for more than 8 hours
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

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

    Inative ingredients

    carbomer 940, ethanol, ethylparaben, glycerol, propylene glycol, purified water, trolamine

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    Cypress, CA 90630 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    90121

  • INGREDIENTS AND APPEARANCE
    CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE KNEE 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL336 mg
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-121-011 in 1 BOX02/10/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2016
    Labeler - United Exchange Corp. (840130579)
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