HOT STUFF- capsicum oleoresin cream

Hot Stuff by

Drug Labeling and Warnings

Hot Stuff by is a Otc medication manufactured, distributed, or labeled by Mueller Sports Medicine LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• simple backache
• arthritis
• strains
• sprains

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

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

• 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

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

• Strains
• Sprains
• Muscle Aches & Pain
• Arthritis
• Joint Pain

6h
Timed-Release
IcePearls™

30805 LBL30805A - 9.16

NET WT 3.75 OZ (106 g)

INGREDIENTS AND APPEARANCE

HOT STUFF 
capsicum oleoresin cream

Product 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)