LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]

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  • LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]

LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]
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NDC 31774-8005-1
Set ID fc5abe34-edf6-400a-bd28-1aea8bac8c70
Category HUMAN OTC DRUG LABEL
Packager Golden Sun Inc DBA Newhall Laboratories
Generic Name
Product Class
Product Number
Application Number PART346
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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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