PRO-FLEX  - camphor, menthol cream 
Nutri-Dyn Products Ltd. dba Professional Health Products

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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PRO-FLEX Cream

Active Ingredients (Percent by weight)           Purpose

Menthol  4.0%  ............................Analgesic              (Pain reliever)

Camphor 4.0%  ...........................Analgesic               (Pain reliever)


Uses for the temporary relief of minor aches and joint pain associated with backpain, arthritis, strains, bruises and sprains.

Warnings

Keep out of the reach of children

If swallowed, get medical help or contact a poison control center right away.

Directions

C13-14 isoparaffin, caprylyl glycol, cetyl alcohol, chondroitin sulfate, denatured alcohol, eucalyptus oil, glucosamine sulfate, glycerin, grape seed oil, laureth-7, methylsulfonylmethane (MSM), oil of lavender, oil of wintergreen, phenoxyethanol, polyacrylamide, polysorbate-20, sea cucumber extract, sorbic, acid, stearyl alcohol, thymol, urea, vitamin E, water


Distributed by:

PROFESSIONAL HEALTH PRODUCTS

4307-49th Street    Innisfail, AB  CANADA T4G 1P3

1-403-227-3926



Pain Reliever


Professional Health Products

                    PRO-FLEX Cream

                            FOR

                      Muscle Pain/Joint Relief

          (Includes MSM, Glucosamine, Chondroitin)

120 net wt. g



www.professionalhealthproducts.com

image of  pro-flex label



PRO-FLEX  
camphor, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49795-227
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cetyl alcohol (UNII: 936JST6JCN)  
Glycol stearate (UNII: 0324G66D0E)  
Dimethyl sulfone (UNII: 9H4PO4Z4FT)  
Glycerin (UNII: PDC6A3C0OX)  
Stearyl alcohol (UNII: 2KR89I4H1Y)  
Glucosamine sulfate (UNII: 1FW7WLR731)  
C13-14 Isoparaffin (UNII: E4F12ROE70)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Urea (UNII: 8W8T17847W)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Caprylyl glycol (UNII: 00YIU5438U)  
Sorbic acid (UNII: X045WJ989B)  
Eucalyptus oil (UNII: 2R04ONI662)  
Methyl salicylate (UNII: LAV5U5022Y)  
Vitamin E (UNII: H4N855PNZ1)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
Thymol (UNII: 3J50XA376E)  
Chondroitin sulfate (bovine) (UNII: 6IC1M3OG5Z)  
CUCUMARIA SEA CUCUMBER (UNII: 3SC3X5I2GC)  
Grape seed oil (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49795-227-01120 g in 1 JAR
2NDC:49795-227-02500 g in 1 BOTTLE, PLASTIC
3NDC:49795-227-035 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2004
Labeler - Nutri-Dyn Products Ltd. dba Professional Health Products (209901511)
Registrant - Nutri-Dyn Products Ltd. dba Professional Health Products (209901511)
Establishment
NameAddressID/FEIBusiness Operations
International Laboratories (Canada) Ltd.247010150manufacture

Revised: 6/2011
Document Id: 8a7de862-5193-4363-aeab-e87ec4a13e68
Set id: 3ca7e006-069f-4991-b457-6d4501673d78
Version: 9
Effective Time: 20110620
 
Nutri-Dyn Products Ltd. dba Professional Health Products