Label: ROCKSAUCE FIERY HOT PAIN RELIEF- methyl salicylate, menthol, capsaicin cream

  • 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 March 17, 2021

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  • ACTIVE INGREDIENT

    Methyl Salicylate 20%

    Menthol 10%

    Capsaicin0.002%

  • PURPOSE

    Topical Analgesic

  • USES:

    Provides soothing heat to sore muscles and joints.

  • WARNINGS:

    For external use only. Avoid contact with eyes, mucous membrane or broken skin.

  • When using this product, do not:

    heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.

  • DO NOT USE

    Do not use otherwise than as directed.

  • ASK DOCTOR

    Consult a doctor and discontinue use if irritation occurs.

    Ask a health professional before use if pregnant or breastfeeding.

    Ask a doctor before using if you have sensitive skin.

  • Keep out of reach of children:

    In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

  • DIRECTIONS:

    Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

  • INACTIVE INGREDIENTS:

    Aminomethyl Propanol, Aloe Barbadensis(Aloe Vera)Leaf Juice, Arnica Montana Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    ROCKSAUCE FIERY HOT PAIN RELIEF 
    methyl salicylate, menthol, capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81683-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.02 g  in 88.5 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0018 g  in 88.5 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE18 g  in 88.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81683-013-0188.5 mL in 1 BOTTLE; Type 0: Not a Combination Product03/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/18/2021
    Labeler - Implus Footcare, LLC (361531585)
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