Label: ROCKSAUCE FIRE- methyl salicylate, menthol and 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 September 29, 2019

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  • Active ingredients

    Methyl Salicylate 20%

    Menthol USP 10%

    Capsaicin 0.002%

  • Purpose

    Topical Analgesic

  • Uses:

    Provides soothing Cold to sore muscles and joints

  • Warnings:

    For external use only.

    Avoid contact with eyes, mucous membrane or broken skin

  • Keep out of reach of children.

    if accidental ingestion, get medical help or call a Poison Control Center right away.

  • Directions:

    Apply liberally to area of pain and massage unti lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to77°F (20°to 25°C).

  • When using this product

    do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

  • Consult a doctor and discontinus use.

    if irritation occurs, ask a health professional before use if pregnant or brastfeeding. before using if you have sensitive skin.

  • Inactive ingredients:

    Water, Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana Extract, Carbomer, Cetearl Alcohol, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Phenoxyethanol, Propylene Glycol, Tocopheryl Acetate

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  • INGREDIENTS AND APPEARANCE
    ROCKSAUCE FIRE 
    methyl salicylate, menthol and capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73344-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 mg  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73344-103-011 in 1 PACKAGE09/29/2019
    188.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:73344-103-021 in 1 PACKAGE09/29/2019
    2355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/29/2019
    Labeler - NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD (404080257)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD404080257manufacture(73344-103)
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