Label: AY BENDITO - THERMOACTIVE- camphor, menthol gel

  • NDC Code(s): 72524-604-04
  • Packager: AY BENDITO INTERNATIONAL, INC
  • Category: HUMAN OTC DRUG LABEL

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 25, 2023

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  • ACTIVE INGREDIENT

    Camphor ………………. 6%

    Menthol …….…………. 4%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Aid for temporary local relief of minor pain in muscles or joints.

  • WARNINGS

    For external use only.

  • WHEN USING

    Use only as directed
    Do not bandage tightly or use with a heating pad
    Avoid contact with eyes and mucous membranes
    Do not apply to wounds or damaged, broken or irritated skin
    A transient burning sensation or redness may occur upon application but generally disappears in several days
    If you experience an allergic reaction, discontinue use and consult a physician

    Do not expose the area treated with product to heat or direct sunlight.

  • STOP USE

    Condition worsens
    Redness is present
    Irritation develops
    Symptoms persist for more than 7 days or clear up occur again within a few days

    You experience signs injury, such as pain, swelling or blistering where the product was applied.

  • PREGNANCY

    IF PREGNANT OR BREAST – FEEDING:

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDEN:

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

  • DOSAGE & ADMINISTRATION

    Adults and Children over 12 years of age:

    Apply a small amount on the affected area.
    Massage in circular motion, let set for a few seconds.
    Repeat as necessary, but no more than 3 to 4 times daily.

    Children under 12 years of age: do not use, consult a doctor.

  • OTHER INFORMATION

    Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

  • INACTIVE INGREDIENT

    Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Arnica Montana Flower Extract, Triethanolamine, Polysorbate 20, Carbomer, Methyl Salicylate, Sodium Chondroitin Sulfate, Glucosamine Sulfate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue No.1 (CI 42090).

  • QUESTION OR COMMENTS?

    Call: +1-787-421-6423

  • AY BENDITO THERMOACTIVE GEL

    AY BENDITO THERMOACTIVE GEL BOTTLE

  • INGREDIENTS AND APPEARANCE
    AY BENDITO - THERMOACTIVE 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72524-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-4 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALCOHOL (UNII: 3K9958V90M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72524-604-0490 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/22/2021
    Labeler - AY BENDITO INTERNATIONAL, INC (081332094)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(72524-604)
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