Label: PHARMACYS PRESCRIPTION- analgesic gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 17, 2014

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS

    MENTHOL 1%

  • Directions

    adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, do not use, consult a doctor.

  • PURPOSE

    Pain relieving gel

  • PURPOSE

    for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • Warnings

    For external use only.

    When using this product, avoid contact with eyes, do not bandage tightly, do not apply to wounds or damaged skin, do not use with heating pads or other heating devices.

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days.

    Keep out of reach of children

  • INACTIVE INGREDIENTS

    carbomer, isopropyl alcohol, nonylphenylpolyoxyethylene ether, camphor, kathon CG, FD&C blue no.1, triethanolamine, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PHARMACYS PRESCRIPTION 
    analgesic gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 87 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-017-08227 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/01/2014
    Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD530766098manufacture(76176-017)
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