Label: LABELLA LINIMENTO OBRERO- capsaicin, menthol, unspecified form, and methyl salicylate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 31774-8005-1 - Packager: Golden Sun Inc DBA Newhall Laboratories
- 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
- PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
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INGREDIENTS AND APPEARANCE
LABELLA LINIMENTO OBRERO
capsaicin, menthol, unspecified form, and methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31774-8005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.25 mg in 1 mL Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form 20 mg in 1 mL Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:31774-8005-1 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part346 01/02/2013 Labeler - Golden Sun Inc DBA Newhall Laboratories (060383791)