Label: ROCKSAUCE ICE- menthol gel

  • 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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  • RockSauce ICE


  • Active Ingredient

    Menthol 6.0%

  • Purpose

    Topical Analgesic

  • Uses

    Provides soothing Cold to sore muscles and joints

  • Warnings

    For external use only.

    Avoid contac with eyes, Mucous membrance or broken skin.

  • When using this products.

  • Consult a doctor and discontinue use

    if irritation occurs, ask a health professional before use if pregnant or brastfeeding. before using if you have sensitive 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° to 77°F (20°to 25°C).

  • Inactive Ingredients

    Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock) Root Extract, Illex Paraguariensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer, Triethanolamine, Silica, Tocopheryl (Vitamin E) Acetate

  • PRINCIPAL DISPLAY PANEL

    RockSauce ICE

    Net wt 3 oz

    DISTRIBUTED BY:

    Rocktape, Inc

    questions: please contact 408-912-7625

    made in china

  • rocksauce ICE

    label image

  • INGREDIENTS AND APPEARANCE
    ROCKSAUCE ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73344-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    MELISSA OFFICINALIS LEAF OIL (UNII: PTP6R7263M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73344-102-0185.125 g in 1 JAR; Type 0: Not a Combination Product09/29/2019
    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)
    Registrant - NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD (404080257)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD404080257manufacture(73344-102)
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