Label: ROCKSAUCE ICE- menthol 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 December 7, 2017

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  • Active ingredients

    Menthol     6%

  • Purpose

    Topical Analgesic

  • Uses:

    For temporary relief minor muscular discomfort

  • Warnings:

    For external use only.

    Avoid contact with eyes, mucous membrane or broken skin

  • Keep out of reach of children.

    if accidentally ingested, getmedical help or contact a Poison Control Center immediately.

  • 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. Store at 68 to 77F (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 conditions persist for more than 1 week or reocur.

  • Inactive ingredients:

    2-amino-2-methyl-1-propanol, Aloe barbadensis (aloe vera) Leaf Extract, Arnica Montana Extract, Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Ethylhexyl, Palmitate, Glycerin, Methylisothiazolinone, Propylene Glycol, Tocopheryl Acetate, Water

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    ROCKSAUCE ICE 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-381
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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:40104-381-011 in 1 PACKAGE12/05/2017
    188.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:40104-381-021 in 1 PACKAGE12/05/2017
    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 finalpart34812/05/2017
    Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(40104-381)
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