PRO-FLEX- camphor, menthol cream

Pro-Flex by

Drug Labeling and Warnings

Pro-Flex by is a Otc medication manufactured, distributed, or labeled by Nutri-Dyn Products Ltd. dba Professional Health Products, International Laboratories (Canada) Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (Percent by weight)           Purpose

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

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

INDICATIONS & USAGE

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

WARNINGS

Warnings

• For external use only.  Avoid contact with eyes.  If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,discontinue use of this product and consult a doctor.
• Do not apply to wounds or damaged skin
• Do not bandage tightly
  

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

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

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years of age and older:  Apply to affected area several times daily.
• Children under 2 years of age:  Do not use, consult a doctor.
  

INACTIVE INGREDIENT

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

REFERENCES

Distributed by:

PROFESSIONAL HEALTH PRODUCTS

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

1-403-227-3926

PURPOSE

Pain Reliever

PRINCIPAL DISPLAY PANEL

Professional Health Products

                    PRO-FLEX Cream

                            FOR

                      Muscle Pain/Joint Relief

          (Includes MSM, Glucosamine, Chondroitin)

120 net wt. g

www.professionalhealthproducts.com

INGREDIENTS AND APPEARANCE

PRO-FLEX  
camphor, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49795-227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49795-227-01	120 g in 1 JAR
2	NDC: 49795-227-02	500 g in 1 BOTTLE, PLASTIC
3	NDC: 49795-227-03	5 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2004

Labeler - Nutri-Dyn Products Ltd. dba Professional Health Products (209901511)

Registrant - Nutri-Dyn Products Ltd. dba Professional Health Products (209901511)

Establishment
Name	Address	ID/FEI	Business Operations
International Laboratories (Canada) Ltd.		247010150	manufacture