FAMILY CARE PAIN RELIEF (MENTHOL) STICK [UNITED EXCHANGE CORPORATION]

FAMILY CARE PAIN RELIEF (MENTHOL) STICK [UNITED EXCHANGE CORPORATION]
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NDC 65923-119-01
Set ID 79778b06-78d5-c616-e053-2a91aa0a78f8
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corporation
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Menthol 2%.........................Topical analgesic

  • PURPOSE

    Uses

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

    Warnings

    For external use only

    Allergy alert: If prone to allergic reaction from aspirin or slicylates, consult a doctor before use.

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product
    • on a child under 12 years of age with arthritis-like conditions
  • DOSAGE & ADMINISTRATION

    Distributed By:

    UNITED EXCHANGE CORPORATION

    Cypress, CA. 90630 USA | 1-888-645-8204 | Made in China

  • 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 eyes, mucous membranes or rashes
    • do not bandage tightly
    • 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

    • redness is present or irritation or rash develops
    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • 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:
    • clean and dry affected area
    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but not more than 4 times daily
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

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

    Inactive ingredients alcohol, hydrogenated castor oil, methyl salicylate, peg-150 distearate, propylene glycol, purified water, sodium stearate

  • PRINCIPAL DISPLAY PANEL

    90120

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE PAIN RELIEF 
    menthol stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-119-010.02 g in 1 TUBE; Type 0: Not a Combination Product10/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/30/2018
    Labeler - United Exchange Corporation (840130579)

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