Label: ROCK SAUCE- methyl salicylate, menthol, capsicum lotion

  • 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 June 2, 2011

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

View All Sections
  • PURPOSE

    Uses: Temporarily relives minor muscular discomfort

  • INDICATIONS & USAGE

    When using this product, do not: heat, microwave, add to hot water or any container where heating water may cause splatterring and result in burns, use in eyes or directly on mucus membrane, take by month or place in nostrils, apply to wounds or damaged skin.

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Ask a doctor before use if you have a cough associated with smoking, excessive phlegm, asthma, emphysema, persistent or chronic cough.

  • DOSAGE & ADMINISTRATION

    Directions: For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily.

  • INACTIVE INGREDIENT

    Inactive Ingredients: D. I. Water, Ethylhexyl Palmitate, Cetearyl Alcohol, Glycerin, Propylene Glycol, Arnica Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Vitamin E Acetate, Carbomer, Triethanolamine, Phenoxyethanol and Methyldibrome Glutarontrile

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children: In case of accidental ingestions, get medical help or call Poison Control Center right away.

  • ACTIVE INGREDIENT

    Active Ingredient

    Methyl Salicylate   20%

    Menthol     10%

    Capsicum   0.05%

  • INFORMATION FOR PATIENTS

    Consult a doctor and discontinue use: If conditions persist for more than 1 week or reoccur.
  • PRINCIPAL DISPLAY PANEL

    MM1label

  • INGREDIENTS AND APPEARANCE
    ROCK SAUCE  
    methyl salicylate, menthol, capsicum lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59663-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE20 mL  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mL  in 100 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM0.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59663-100-01120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/13/2012
    Labeler - Shine & Pretty (USA), Corp. (603528605)
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!