Renovo Patch

Manufacturer
TMIG, Inc.
Effective date
2015-01-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 20:20:12

Label at a glance#

ProductRenovo
Active ingredientMENTHOL, CAPSAICIN
Label structure7 sections

Indications and uses

Renovo Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness. Renovo Patch is an external analgesic/counterirritant.

Dosage and administration

Renovo patch contains 0.0375% capsaicin and 5.00% menthol. Instructions for Use Clean and dry affected area Cut open pouch and remove patch Remove protective film and apply directly to area of pain Apply to affected area not more than 3 times daily Wash hands with soap after applying patch Reseal pouch containing unused patches Directions Adults and children 12 years and over apply to affected area change patch 1 ...

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Renovo Patch contains capsaicin and menthol in a localized dermal delivery system. The capsaicin in Renovo is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water. The menthol is slightly soluble in water.

Renovo is a single-use patch stored in a foil pouch.  Each Renovo patch is 8.3 cm x 12.5 cm (104 cm2) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture, and covered with a removable polyester release liner.

The empirical formula for capsaicin is C18H27NO3, with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:

Figure 1
Figure 1

The empirical formula for menthol is C10H20O, with a molecular weight of 156.27. The chemical compound menthol [(1R,2S,5R)-2-isopropyl-5-methylcyclohexanol ] is an activating ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8). It has the following structure:

Menthol chair conformation
Menthol chair conformation

Each Relovo Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch).  The Renovo patch contains the following inactive ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodiumm Salt, Glycerin, Iodoproynyl Butylcabamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Renovo Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Renovo Patch is an external analgesic/counterirritant.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Renovo Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS

WARNINGS SECTION

  • For external use only.
  • Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.
  • Consult physician for children under 12.
  • Do not use if you are allergic to Menthol.
  • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs.
  • KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Renovo patch contains 0.0375% capsaicin and 5.00% menthol.

Instructions for Use

  • Clean and dry affected area
  • Cut open pouch and remove patch
  • Remove protective film and apply directly to area of pain
  • Apply to affected area not more than 3 times daily
  • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches

Directions

Adults and children 12 years and over
  • apply to affected area
  • change patch 1 to 2 times daily
Children under 12 years
  • consult physician before use

HOW SUPPLIED

HOW SUPPLIED SECTION

Renovo Patch is supplied in cartons with either 1 re-sealable pouch containing 3 patches or 3 re-sealable pouches each containing 5 patches.

NDC 69176-025-03       3 Patches per carton

NDC 69176-025-15     15 Patches per carton

Storage: Store below 25°C. Avoid direct sunlight.

Distributed by:
TMIG, Inc., Marietta, GA 30062
770-579-8883

Manufactured by:
Pocono Coated Products, LLC
Greensboro, N.C. USA 27407

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0fb9595b-figure-03
0fb9595b-figure-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchPSN8
1300889capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD8
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69176-025-032020-01-31C16284748780-19d75b9d1-08d3-f424-e053-dadaa90a57ceRenovo Patch
69176-025-152020-01-31C16284748780-19d75b9d1-08d3-f424-e053-dadaa90a57ceRenovo Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69176-025-03Renovo100 g in 1 PATCHPATCH1008
69176-025-03Renovo3 in 1 CARTONPATCH38
69176-025-15Renovo15 in 1 CARTONPATCH158
69176-025-15Renovo100 g in 1 PATCHPATCH1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69176-025RENOVO (MENTHOL AND CAPSAICIN) PATCH [TMIG, INC.]8Legacy NDC, 4 package rows20150127_d82548c9-d015-4339-bb4b-ae397fa863e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69176-025-03EA - Each69176-0257fa2975d-327a-4743-b241-ccfcd649b3c412014-11-05
69176-025-15EA - Each69176-025633cd9a9-ee1b-4ddf-803f-a69b199ed3e012014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM8
MENTHOLACTIVE INGREDIENTL7T10EIP3A8
CAPSAICINACTIVE MOIETYS07O44R1ZM8
MENTHOLACTIVE MOIETYL7T10EIP3A8
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X8
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW48
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K8
GLYCERININACTIVE INGREDIENTPDC6A3C0OX8
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H8
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH8
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2J8
WATERINACTIVE INGREDIENT059QF0KO0R8

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69176-02569176-025-15, 69176-025-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 7 · 380 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IRRIGATION2 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 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
0fb9595b-edd5-458d-bec4-07ac956c72cdd82548c9-d015-4339-bb4b-ae397fa863e42015-01-26WarningsExact identifier
spl id: 0fb9595b-edd5-458d-bec4-07ac956c72cd
spl set id: d82548c9-d015-4339-bb4b-ae397fa863e4

Reported adverse events (FAERS/openFDA)#

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