Label: PAINZAWAY PAIN RELIEVING GEL- menthol gel

  • NDC Code(s): 10578-135-05
  • Packager: Indiana Botanic Gardens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Active Ingredient

    Menthol 4.6%

  • Purpose

    topical analgesic

  • Uses

    ■ Temporary relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises and sprains. ■ Provides cooling pain relief.

  • Warnings

    For external use only

  • When using this product

    ■ Do not heat ■ Do not microwave ■ Do not use near open flame ■ Do not add to hot water or any container when heating water. May cause splattering and result in burns. ■ Avoid contact with eyes ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly

  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ See the important warnings under "when using this product"

    ■ 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: Consult a physician.

  • Other Information:

    Use only if seal is unbroken.

  • Inactive Ingredients

    Aloe Vera Concentrate, Carbomer 940, Emu Oil, FD&C Blue #1, Glucosamine Sulfate, Glycerin, Green Tea Fragrance, Imidazolidinyl Urea, MSM Powder, Propylene Glycol, SD Alcohol 39B, Triethanolamine, Water

  • Questions?

    1-800-644-8327

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY
    INDIANA BOTANIC GARDENS, INC.
    3401 W. 37TH AVE., HOBART, IN 46342
    Website: BotanicChoice.com

  • PRINCIPAL DISPLAY PANEL

    PainzAway®

    PAIN RELIEVING GEL

    NET WT. 5 OZ.

    label

  • INGREDIENTS AND APPEARANCE
    PAINZAWAY PAIN RELIEVING GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    TEA LEAF OIL (UNII: VC855RRT77)  
    IMIDUREA (UNII: M629807ATL)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-135-0557 g in 1 JAR; Type 0: Not a Combination Product04/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/19/2022
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771manufacture(10578-135)
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