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
  • 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 April 1, 2022

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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)  
    TEA LEAF OIL (UNII: VC855RRT77)  
    IMIDUREA (UNII: M629807ATL)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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 not finalpart34804/19/2022
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771manufacture(10578-135)
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