Label: AY BENDITO - THERMOACTIVE- camphor, menthol lotion

  • NDC Code(s): 72524-010-03
  • Packager: AY BENDITO INT'L THERMO ANALGETICS ROLL-ON
  • 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

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 doctor

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

  • STOP USE

    STOP USE AND ASK A DOCTOR IF:

    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 OR BREAST FEEDING

    IF PREGNANT OR BREAST – FEEDING:

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 LOTION ROLL ON

    THERMOACTIVE ROLL ON

  • INGREDIENTS AND APPEARANCE
    AY BENDITO - THERMOACTIVE 
    camphor, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72524-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)6 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72524-010-0390 g in 1 BOTTLE; Type 0: Not a Combination Product09/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/17/2018
    Labeler - AY BENDITO INT'L THERMO ANALGETICS ROLL-ON (081332094)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(72524-010)