PRO-FLEX Cream

Manufacturer
Nutri-Dyn Products Ltd. dba Professional Health Products | International Laboratories (Canada) Ltd.
Effective date
2011-06-20
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 22:28:21

Label at a glance#

ProductPro-Flex
Active ingredientCAMPHOR (NATURAL), Menthol
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (Percent by weight)           Purpose

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

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

Distributed by:

PROFESSIONAL HEALTH PRODUCTS

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

1-403-227-3926

OTC - PURPOSE SECTION


Pain Reliever

PACKAGE LABEL.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

image of pro-flex labelimage of pro-flex label

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49795-227PRO-FLEX (CAMPHOR, MENTHOL) CREAM [NUTRI-DYN PRODUCTS LTD. DBA PROFESSIONAL HEALTH PRODUCTS]9Legacy NDC20110621_3ca7e006-069f-4991-b457-6d4501673d78.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9419
MentholACTIVE INGREDIENTL7T10EIP3A9
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9419
MentholACTIVE MOIETYL7T10EIP3A9
C13-14 IsoparaffinINACTIVE INGREDIENTE4F12ROE709
Caprylyl glycolINACTIVE INGREDIENT00YIU5438U9
Cetyl alcoholINACTIVE INGREDIENT936JST6JCN9
Chondroitin sulfate (bovine)INACTIVE INGREDIENT6IC1M3OG5Z9
CUCUMARIA SEA CUCUMBERINACTIVE INGREDIENT3SC3X5I2GC9
Dimethyl sulfoneINACTIVE INGREDIENT9H4PO4Z4FT9
Eucalyptus oilINACTIVE INGREDIENT2R04ONI6629
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR7319
GlycerinINACTIVE INGREDIENTPDC6A3C0OX9
Glycol stearateINACTIVE INGREDIENT0324G66D0E9
Grape seed oilINACTIVE INGREDIENT930MLC8XGG9
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4M9
Methyl salicylateINACTIVE INGREDIENTLAV5U5022Y9
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T9
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YH9
Sorbic acidINACTIVE INGREDIENTX045WJ989B9
Stearyl alcoholINACTIVE INGREDIENT2KR89I4H1Y9
ThymolINACTIVE INGREDIENT3J50XA376E9
UreaINACTIVE INGREDIENT8W8T17847W9
Vitamin EINACTIVE INGREDIENTH4N855PNZ19
WaterINACTIVE INGREDIENT059QF0KO0R9

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49795-22749795-227-01, 49795-227-02, 49795-227-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 190 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
Stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YCAPSULE, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
Stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
12 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
ThymolTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BSOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
UreaUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii candidate
7 equally ranked IID candidates
UreaUREA8W8T17847WTABLET, COATED / ORAL0.02 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
Stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii candidate
12 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
UreaUREA8W8T17847WTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
7 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Vitamin E.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
Methyl salicylateMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET / ORAL17 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BEMULSION / OPHTHALMIC1 mgExact identifier — unii candidate
19 equally ranked IID candidates
Stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / VAGINAL425 mgExact identifier — unii candidate
12 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BSOLUTION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
Stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YTABLET, EXTENDED RELEASE / ORAL244 mgExact identifier — unii candidate
12 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sorbic acidSORBIC ACIDX045WJ989BTABLET, FILM COATED, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Methyl salicylateMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
Cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
435741fe-09ac-9ecf-e063-6394a90adbce3ca7e006-069f-4991-b457-6d4501673d782025-11-11WarningsExact identifier
spl set id: 3ca7e006-069f-4991-b457-6d4501673d78

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.