MIRACLE PLUS NECK AND SHOULDER PAIN RELIEF- capsaicin gel 
Concept Laboratories, Inc.

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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Miracle Plus® Neck & Shoulder Pain Relief

Drug Facts

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.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, 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

  • 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 HCl, 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

Manufactured by Concept Laboratories, Inc., Chicago, IL 60642

PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

MIRACLE
PLUS
®

Neck & Shoulder
Pain Relief

with Capsaicin

Fast Relief from:

  • Muscle Pain
  • Joint Pain
  • Backache
  • Arthritis

Greaseless • Odorless • with Aloe Vera

NET WT 4 OZ (113 g)

Principal Display Panel - 113 g Bottle Label
MIRACLE PLUS NECK AND SHOULDER PAIN RELIEF 
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-713
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.02825 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALFALFA LEAF (UNII: HY3L927V6M)  
CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
GINKGO (UNII: 19FUJ2C58T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EMU OIL (UNII: 344821WD61)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-713-44113 g in 1 BOTTLE; Type 0: Not a Combination Product07/09/201211/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34807/09/201211/01/2016
Labeler - Concept Laboratories, Inc. (962282612)

Revised: 10/2017
 
Concept Laboratories, Inc.