Label: ELGIN PAIN RELIEF- menthol gel

  • 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 May 9, 2023

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  • OTC-ACTIVE INGREDIENT SECTION

    Active Ingedients Purpose

    Menthol USP 3.5%................... Topical Analgesic

  • Purpose

    Menthol USP 3.5% Topical Analgesic

  • Warnings

    Warnings:

    For external use only.

  • Directions:

    Directions:

    Adults and children 2 years of age and older:

    Apply to painful muscles and joints. Genthly massage throughly into affected area.

    Repeat as necessary but not more than 4 times daily.

  • Ask a doctor before use if you have:

    Ask a doctor before use if you have sensitive skin.

  • When using this product:

    When using this product:

    Avoid contact with the eyes or mucous membranes.

    Do not apply to wounds or damaged skin.

    Do not use with other ointments , creams, sprays or linaments.

    Do not apply to irrated skin or excessive irration develops.

    Do not bandage.

    Wash hands after use with cool water.

    Dop not use with heating pad or device.

  • Stop Use and ask a doctor if::

    Stop use and ask a Dictor if: Condition worsens, or if symptoms persist for more than 7 days or clear up and reoccur.

  • If pregnant 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 accidenthly ingested get medical help or contact a Poison Control Center.

  • Inactive Ingredients:

    Aqueous (Deionized filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *IlexParaguariensis leaf extract, Cinnamomum Camphora (camphor),Tocopheryl Avetate (Vitamin E Acetate), Carbomer, FD&C Blue #1, FD&C Yellow #5, Methylparaben, Triethanolamine.

  • Dosage and Administration

    Directions:

    Adults and children 2 years of age and older

    Apply to painful muscles and joints. Genthly massage thoroughly into affected area.

    Repeat as necessary but not more than 4 times daily.

  • Other information:

    Other information: Stiore in a cool dry place with lid closed tightly.

  • USES:

    USES:
    Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

  • Principle Display Panel

    30056-004-16

  • INGREDIENTS AND APPEARANCE
    ELGIN PAIN RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30056-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30056-004-16454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/11/2016
    Labeler - Eco-Logics, Inc. (047667022)
    Registrant - Elginex Corporation (005142799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Essentials,Inc.947484713manufacture(30056-004)
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