Miracle Plus Overnight
FDA Label NDC 64058-155

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Concept Laboratories, Inc. for the product Miracle Plus Overnight (NDC 64058-155). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

  • do not apply to wounds or damaged skin
  • do not bandage tightly

    • Manufactured by Concept Laboratories, Inc., Chicago, IL 60642 #BG-MP9874

Active Ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose

Pain Relieving

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

For external use only.

Otc - Do Not Use

  • Do not use with heating pad, wrap, hot water bottle or any heating element.

Otc - When Using

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

Otc - Pregnancy Or Breast Feeding

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

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

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)

        Principal Display Panel (113 g Bottle Label)

        Principal Display Panel (113 g Bottle Label)

* Please review the disclaimer below.