HOT STUFF- capsicum oleoresin cream 
Mueller Sports Medicine LLC

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.

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Hot Stuff®

Drug Facts

Active ingredient

Capsicum Oleoresin 0.0625%
(Containing Capsaicin 0.025%)

Purpose

Pain Relief

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

Warnings

For external use only.

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

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away

  • if pregnant or nursing, seek the advice of a health professional before using

Directions

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

Questions or comments?

Call 1-800-356-9522 or Email us at sportcare@muellersportsmed.com

PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

MUELLER®

Hot Stuff®
Cream
topical analgesic

Warming Capsaicin formula
delivers comforting,
targeting relief

HELPS TO RELIEVE PAIN
ASSOCIATED WITH

6h
Timed-Release
IcePearls™

30805 LBL30805A - 9.16

NET WT 3.75 OZ (106 g)

PRINCIPAL DISPLAY PANEL - 106 g Bottle Label
HOT STUFF 
capsicum oleoresin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52564-308
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN0.0265 g  in 106 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52564-308-02106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2016
2NDC:52564-308-01106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/201403/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/25/2014
Labeler - Mueller Sports Medicine LLC (006426316)

Revised: 11/2016
Document Id: 0e201221-d807-4594-8c71-d329e260a59f
Set id: 3abb8b85-5a19-4173-aacf-92d88ac30060
Version: 2
Effective Time: 20161111
 
Mueller Sports Medicine LLC