Label: HOT STUFF- capsicum oleoresin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52564-308-01, 52564-308-02 - Packager: Mueller Sports Medicine LLC
- 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 11, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pad, pack, wrap, hot water bottle or any heating element
When using this product do not get into eyes
- avoid contact with other mucous membranes
Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
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Directions
- Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
- Children under 12 years of age consult a physician
- Apply a thin layer to affected area not more than 3 to 4 times daily
- Gently massage into the skin until fully absorbed
- Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
- A burning sensation may occur upon initial application but generally disappears with continued use
- For a severe burning discomfort, remove excess product wiht a soft cloth and mineral oil
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Inactive ingredients
Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita (Peppermint) Oil, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide
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- PRINCIPAL DISPLAY PANEL - 106 g Bottle Label
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INGREDIENTS AND APPEARANCE
HOT STUFF
capsicum oleoresin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52564-308 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN 0.0265 g in 106 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) SUNFLOWER OIL (UNII: 3W1JG795YI) ALFALFA (UNII: DJO934BRBD) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ROSEMARY (UNII: IJ67X351P9) MENTHA PIPERITA LEAF (UNII: A389O33LX6) ASIAN GINSENG (UNII: CUQ3A77YXI) GINKGO (UNII: 19FUJ2C58T) FLAX SEED (UNII: 4110YT348C) ACAI (UNII: 46AM2VJ0AW) PEPPERMINT OIL (UNII: AV092KU4JH) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) LAURYL LAURATE (UNII: GPW77G0937) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) HYDRATED SILICA (UNII: Y6O7T4G8P9) STARCH, CORN (UNII: O8232NY3SJ) CETEARYL ISONONANOATE (UNII: P5O01U99NI) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETEARETH-12 (UNII: 7V4MR24V5P) CETYL PALMITATE (UNII: 5ZA2S6B08X) EMU OIL (UNII: 344821WD61) POLYSORBATE 20 (UNII: 7T1F30V5YH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52564-308-02 106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2016 2 NDC:52564-308-01 106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/25/2014 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 06/25/2014 Labeler - Mueller Sports Medicine LLC (006426316)