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Name:Biorelief Ice Pain Relieving
Manufacturer:Mekt, Llc
Category:Over-the-counter (OTC) Marketed Drugs


BioRelief Ice Pain Relieving Spray

BIORELIEF ICE PAIN RELIEVING  - menthol spray 
Mekt, LLC

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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BioRelief Ice Pain Relieving Spray

Active ingredient                         Purpose

Menthol 10.00%.........................Topical analgesic

Uses temporarily relieves minor pain associated with: -simple backache -muscle strains -sprains -bruises

Warnings For external use only

When using this product -use only as directed -avoid contact with eyes and mucous membrances -do not bandage tightly or use with a heating pad -do not apply to wounds or broken or irritated skin

Stop use and ask a doctor if -condition worsens -irritation develops -symptoms persist for more than 7 days, or if condition clears up and occurs again within a few days  If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions -adults and children over 18 years: spray directly onto affected area, repeat as necessary but no more than 4 times daily -children under 18 years: ask a doctor -wash hands with soap and water after applying

Inactive ingredients SD-Alcohol 40B, Aqua (Deionized Water), Isopropyl Alcohol, Dimethyl Sulfone (MSM), Glucosamine Sulfate, Chondroitin Sulfate, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Oil, liex Paraguariensis Leaf Extract, Citric Acid, Arnica Montana Flower Extract, FD and C Blue #1

Distributed by MEKT, LLC, Boca Raton, FL 33432 www.BioFormulas.com  7 05105 34916 9

Bio Relief   ICE  PAIN RELIEVING SPRAY  With  ILEX  Arnica, MSM, Chondroitin, Glucosamine  Long Lasting, Deep Penetrating Pain Relief  -Arthritis -Muscles and Joints -Backache  Net Wt. 2 oz

Bio Relief Pain Relieving Spray


BIORELIEF ICE PAIN RELIEVING 
menthol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76019-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 59 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
WATER  
ISOPROPYL ALCOHOL  
DIMETHYL SULFONE  
GLUCOSAMINE SULFATE  
PEPPERMINT OIL  
CORYMBIA CITRIODORA LEAF OIL  
CITRIC ACID MONOHYDRATE  
ARNICA MONTANA FLOWER  
FD&C BLUE NO. 1  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76019-100-02 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 59 mL in 1 BOTTLE This package is contained within the CARTON (76019-100-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 02/14/2011

Labeler - Mekt, LLC (609247494)
Establishment
Name Address ID/FEI Operations
Pure Source Inc. 969241041 manufacture

Revised: 02/2011 Mekt, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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