Hot Stuff®

Hot Stuff®
SPL v2
SPL
SPL Set ID 3abb8b85-5a19-4173-aacf-92d88ac30060
Route
TOPICAL
Published
Effective Date 2016-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Butylene Glycol Glycerin Aloe Vera Leaf Sunflower Oil Alfalfa Arnica Montana Flower Rosemary Mentha Piperita Leaf Asian Ginseng Ginkgo Flax Seed Acai Peppermint Oil Glucosamine Hydrochloride Dimethyl Sulfone Lauryl Laurate Methyl Diisopropyl Propionamide Ethyl Menthane Carboxamide Menthyl Lactate, (-)- Hydrated Silica Starch, Corn Cetearyl Isononanoate Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl Monostearate Ceteareth-12 Cetyl Palmitate Emu Oil Polysorbate 20 .alpha.-tocopherol Acetate Edetate Disodium Anhydrous Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-25 Until 2018-03-01

Description

Drug Facts

Purpose

Pain Relief


Medication Information

Purpose

Pain Relief

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
Section 50567-7

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

Section 53414-9
  • if pregnant or nursing, seek the advice of a health professional before using
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
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
Active Ingredient

Capsicum Oleoresin 0.0625%

(Containing Capsaicin 0.025%)

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 [email protected]

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)


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
Section 50567-7 (50567-7)

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

Section 53414-9 (53414-9)
  • if pregnant or nursing, seek the advice of a health professional before using
Purpose

Pain Relief

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
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
Active Ingredient (Active ingredient)

Capsicum Oleoresin 0.0625%

(Containing Capsaicin 0.025%)

Inactive Ingredients (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? (Questions or comments?)

Call 1-800-356-9522 or Email us at [email protected]

Principal Display Panel 106 G Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

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