Miracle ®

Miracle ®
SPL v1
SPL
SPL Set ID e2041558-6091-4093-9fc6-44a93df3f0d4
Route
TOPICAL
Published
Effective Date 2014-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.02825 g)
Inactive Ingredients
Water Glycerin Peg-75 Lanolin Dimethyl Sulfone Aloe Vera Leaf Alfalfa Leaf Cymbopogon Schoenanthus Leaf Glucosamine Hydrochloride Ginkgo Polysorbate 20 Emu Oil Dmdm Hydantoin Propylene Glycol Methylparaben Propylparaben Asian Ginseng .alpha.-tocopherol Acetate Polyoxyl 40 Hydrogenated Castor Oil Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-11-20

Description

Drug Facts

Purpose

Pain Relieving


Medication Information

Purpose

Pain Relieving

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
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 50566-9

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 50567-7

When using this product do not get into eyes

  • avoid contact with other mucous membranes
Section 50570-1
  • Do not use with heating pad, wrap, hot water bottle or any heating element.
Section 53414-9
  • if pregnant or nursing, seek the advice of a health professional before using
Warnings

For external use only.

Directions
  • 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
Active Ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Other Information
  • It is recommended to test for skin sensitivity prior to use. Apply product to a small area, follow the directions and wait 24 hours. Proceed with application if no adverse reaction.
  • A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.
  • If applying product to hands, wait 30 minutes before washing.
  • Avoid water, heat, or direct sunlight while using product.
  • If wearing contact lenses, insert prior to application and avoid touching them after applying product.
  • If eye contact occurs, flush immediately with water.
Inactive Ingredients

Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Glucosamine HCI, Emu Oil, Dimethyl Sulfone, Celosia Argentea Seed Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Tocopheryl Acetate, DMDM Hydantoin, Propylene Glycol, Methylparaben, Propylparaben.

Questions Or Comments?

Call 1-888-373-8831 or visit www.conceptlabs.org

Principal Display Panel 113 G Bottle Label

MIRACLE ®

PLUS

OVERNIGHT

PAIN RELIEVING

GEL

odor-free

pain relief

IMMEDIATE

RELIEF

  • Warming, soothing pain relief
  • Stainless, greaseless formula
  • Temporarily relieves backaches,

    muscle aches, joint pain, and arthritis

4 OZ. (113 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
  • bruises
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 50566-9 (50566-9)

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 50567-7 (50567-7)

When using this product do not get into eyes

  • avoid contact with other mucous membranes
Section 50570-1 (50570-1)
  • Do not use with heating pad, wrap, hot water bottle or any heating element.
Section 53414-9 (53414-9)
  • if pregnant or nursing, seek the advice of a health professional before using
Purpose

Pain Relieving

Warnings

For external use only.

Directions
  • 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
Active Ingredient (Active ingredient)

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Other Information (Other information)
  • It is recommended to test for skin sensitivity prior to use. Apply product to a small area, follow the directions and wait 24 hours. Proceed with application if no adverse reaction.
  • A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.
  • If applying product to hands, wait 30 minutes before washing.
  • Avoid water, heat, or direct sunlight while using product.
  • If wearing contact lenses, insert prior to application and avoid touching them after applying product.
  • If eye contact occurs, flush immediately with water.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Glucosamine HCI, Emu Oil, Dimethyl Sulfone, Celosia Argentea Seed Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Tocopheryl Acetate, DMDM Hydantoin, Propylene Glycol, Methylparaben, Propylparaben.

Questions Or Comments? (Questions or comments?)

Call 1-888-373-8831 or visit www.conceptlabs.org

Principal Display Panel 113 G Bottle Label (PRINCIPAL DISPLAY PANEL - 113 g Bottle Label)

MIRACLE ®

PLUS

OVERNIGHT

PAIN RELIEVING

GEL

odor-free

pain relief

IMMEDIATE

RELIEF

  • Warming, soothing pain relief
  • Stainless, greaseless formula
  • Temporarily relieves backaches,

    muscle aches, joint pain, and arthritis

4 OZ. (113 g)


Advanced Ingredient Data


Raw Label Data

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