ROCK SAUCE (METHYL SALICYLATE, MENTHOL, CAPSICUM) LOTION [SHINE & PRETTY (USA), CORP.]

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ROCK SAUCE (METHYL SALICYLATE, MENTHOL, CAPSICUM) LOTION [SHINE & PRETTY (USA), CORP.]
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NDC 59663-100-01
Set ID 79373f11-070b-4495-b9cf-6bb94a994430
Category HUMAN OTC DRUG LABEL
Packager Shine & Pretty (USA), Corp.
Generic Name
Product Class
Product Number
Application Number PART348
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  • 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)
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