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

If you are a consumer or patient please visit this version.

View All Sections
  • RockSauce ICE


  • Active Ingredient

    Menthol 6.0%

  • Purpose

    Topical Analgesic

  • Uses

    Provides soothing cold to sore muscles

  • 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 membane, take by mouth or place in nostrils, apply to wounds or damaged skin.

    Do not use otherwise than as directed.

  • Consult a doctor and discontinue use

    if irritation occurs.

  • Keep out of reach of children.

    In case of accidental ingestion, get medical help or call a Poison Control Center right away.

  • Directions

    Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. See important warnings under "When using this product". Not for childern 5 years or younger. 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, Ilex 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 2.5g

    Icy cold pain relief cream

    Soothies sore muscles and joints

    DISTRIBUTED BY:

    Rocktape, Inc

    questions: please contact 408-912-7625

    made in china

  • rock sauce chill

    label image

  • INGREDIENTS AND APPEARANCE
    ROCKSAUCE ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73344-101
    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
    WATER (UNII: 059QF0KO0R)  
    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:73344-101-012.5 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(73344-101)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!