MIRACLE PLUS OVERNIGHT  PAIN RELIEVING- 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 Overnight
Pain Relieving Gel

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

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

Other information

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

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

PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

MIRACLE®
PLUS

OVERNIGHT

PAIN RELIEVING
GEL

odor-free
pain relief

IMMEDIATE
RELIEF

4 OZ. (113 g)

Principal Display Panel - 113 g Bottle Label
MIRACLE PLUS OVERNIGHT   PAIN RELIEVING
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-155
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)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-155-44113 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:64058-155-4257 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34811/20/2014
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-155)

Revised: 12/2014
Document Id: a56b263a-5d26-44fe-a476-4fc6ef6d3913
Set id: e2041558-6091-4093-9fc6-44a93df3f0d4
Version: 1
Effective Time: 20141203
 
Concept Laboratories, Inc.