Label: ELGIN PAIN RELIEF- menthol gel

  • NDC Code(s): 30056-004-28, 30056-004-32
  • Packager: Eco-Logics, Inc.
  • 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

  • Uses

    USES:

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

  • Warning

    Warning

    For external Use only.

  • Directions

    ADirections:

    Adults and children 2 years of age and older:

    Apply to painful muscles and joints. Genthly massage thtoughly into affected areas.

    Repeat as necessary but not more than 4 times daily.

  • Ask doctor before use if you:

    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 nopt apply to irrated skin or ifexcessive irration develops.

    Do not bandage.

    Wash hands after use with cool water.

    Do not use with heating pad or device.

  • Stop Use and Ask a Doctor if:

    Stop use and Ask doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

  • Keep out of reach of children:

    Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center.

  • 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.

  • Other information

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

  • Inactive Ingredients

    Inactive Ingredients:

    Aqueou(Deionized water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *Ilex Paraguariensis Leaf Extract, Cinnamomum Camphora (camphor), Tocopheryl Acetate (Vitamin E Acetate) Carbomer, FDC Blue #1, FDC Yellow#5, Methylparaben, Triethanolamine.

  • If pregnant or breast feeding:

    If pregrant or breast feeding. Ask a health professional before use.

  • Principle Dislay Panel

    30056-004-3230056-004-28

  • 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:30056-004-283780 g in 1 JUG; Type 0: Not a Combination Product07/11/2016
    2NDC:30056-004-32877 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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