FDA.reportPublic FDA data

Ultimate Topical Pain Relief Patch

Manufacturer
Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2017-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:53

Label at a glance#

ProductUltimate Topical Pain Relief Patch
Active ingredientMENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and muscle pain associated with simple back ache, arthritis, strains and sprains. Use only as directed.

Dosage and administration

Adults and children 12 and over apply to affected area; change patch 1 to 2 times daily Children under 12 years: Consult physician before use.

Storage and handling

Store below 25°C (77°F). Avoid direct sunilght.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.00%

Capsaicin 0.0375%

Purpose:

OTC - PURPOSE SECTION

External Analgesic/Counterirritant

External Analgesic/Counterirritant

Uses:

INSTRUCTIONS FOR USE SECTION

Temporarily relieves minor aches and muscle pain associated with simple back ache, arthritis, strains and sprains. Use only as directed.

Warnings

WARNINGS SECTION

  • For external useonly.
  • Avoid contact with eyes and mucous membranes.
  • Do not use on wounds or damaged skin.
  • Do not cover with bandage.
  • Do not use if you are allergic to Menthol.
  • Consult physician for use on children under 12.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

conditions worsen, if symptoms persist for more than 7 days or clear up and occur again with a few days, or if a rash,

itching or excessive skin irritation occurs.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

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

Other Information

STORAGE AND HANDLING SECTION

Store below 25°C (77°F). Avoid direct sunilght.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium ,Glycerin, Iodopropynyl Butylcarbamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.

Questions or Comments?

OTC - QUESTIONS SECTION

Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Ultimate Topical Pain Relief Patch contains 0.0375% capsaicin and 5.00% menthol

Ultimate Topical Pain Relief Patch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box ImageBox Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchPSN2
1300889capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD2
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchSY2

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69159-910-05Ultimate Topical Pain Relief Patch5 in 1 POUCHPATCH52
69159-910-05Ultimate Topical Pain Relief Patch1 in 1 CARTONPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69159-910ULTIMATE TOPICAL PAIN RELIEF PATCH (CAPSAICIN AND MENTHOL, UNSPECIFIED FORM) PATCH [FOSHAN AQUA GEL BIOTECH CO.,LTD.]2Current NDC, Legacy NDC, 2 package rows20171106_33c9f8ba-903e-249e-e054-00144ff8d46c.zip

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
69159-91069159-910-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT

Source Document#

Source XML

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
Ultimate Topical Pain Relief PatchCAPSAICIN AND MENTHOL, UNSPECIFIED FORMFoshan Aqua Gel Biotech Co.,Ltd.33c9f8ba-903e-249e-e054-00144ff8d46c2017-11-06WarningsExact identifier
ndc (package): 69159-910-05
ndc (product): 69159-910
ndc11 (package): 69159091005
spl id: 5d53bb54-e7d7-724f-e053-2a91aa0a5618
spl set id: 33c9f8ba-903e-249e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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