Label: LABELLA LINIMENTO OBRERO- capsaicin, menthol, unspecified form, and methyl salicylate 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 November 6, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Capsaicin 0.025%Topical Analgesic
    Menthol 2.0%Topical Analgesic
    Methyl Salicylate 10%Topical Analgesic
  • Use

    • Temporarily relieves the minor aches and pains of muscle and joints.
  • Warnings

    • For external use only.
    • Keep this and all other drugs out of the reach of children.
    • If swallowed, get medical help or contact a Poison Control Center immediately.

    When using this product

    • Avoid contact with eyes.
    • Do not bandage tightly.
    • Do not apply to wounds or broken skin.
    • If condition worsens or if symptoms persist for more than 7 days, discontinue use of this product and consult a physician.
  • Directions

    • Use only as directed.
    • Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: consult a physician.
  • Inactive Ingredients

    Water (Aqua), Stearic Acid, Isopropyl Palmitate, Propylene Glycol, Cetyl Alcohol, Glyceryl Monostearate, Thiethanolamine, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Carbomer, Methylparaben, Propylparaben, Sorbitan Sesquioleate, Tetra Sodium EDTA.

  • Questions?

    www.labellabeauty.com

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Newhall Laboratories, Inc.
    5 High Ridge Park, Suite 100
    Stamford, CT 06905

  • PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

    LA BELLA™

    LINIMENTO
    OBRERO

    Pain Relieving Cream
    with Chile Extract

    Relieves minor aches & pains

    Net Wt. 8 FL. OZ. (236 ml)

    PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    LABELLA LINIMENTO OBRERO 
    capsaicin, menthol, unspecified form, and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31774-8005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.25 mg  in 1 mL
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form20 mg  in 1 mL
    Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31774-8005-1236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34601/02/2013
    Labeler - Golden Sun Inc DBA Newhall Laboratories (060383791)
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