FDA.reportPublic FDA data

Ultra Strength Pain Relief Balm

Manufacturer
McCure Health Solutions Inc. | Jiangsu Dedi Medical Device Co., Ltd.
Effective date
2016-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:48:16

Label at a glance#

ProductUltra Strength Pain Relief Balm
Active ingredientCAMPHOR (NATURAL), MENTHOL
Label structure7 sections

Indications and uses

For temporary relief minors aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

Dosage and administration

Rub well on the affected area. Repeat 3 to 4 times daily

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 11%

Menthol 11%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief minors aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes and mocous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Severe skin irritation occurs.
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rub well on the affected area. Repeat 3 to 4 times daily

Other information

SPL UNCLASSIFIED SECTION

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

CAJUPUT OIL, CLOVE OIL, DEMENTHOLIZED MINT OIL, PARAFFIN PETROLATUMA

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAIN RELIEF BALMPAIN RELIEF BALM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1607622camphor 11 % / menthol 11 % Topical GelPSN3
1607622camphor 0.11 MG/MG / menthol 0.11 MG/MG Topical GelSCD3
1607622camphor 11 % / menthol 11 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52486-013-182020-01-31C16284748780-19d75b9d0-e5ea-f424-e053-dadaa90a57ceUltra Strength Pain Relief Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52486-013-18Ultra Strength Pain Relief Balm1 in 1 CARTONGEL13
52486-013-18Ultra Strength Pain Relief Balm18 g in 1 TUBEGEL183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52486-013ULTRA STRENGTH PAIN RELIEF BALM (CAMPHOR, MENTHOL) GEL [MCCURE HEALTH SOLUTIONS INC.]3Legacy NDC, 2 package rows20161228_0db4294b-4451-4063-a442-bbf3078bc806.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9412
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9412
MENTHOLACTIVE MOIETYL7T10EIP3A2
CAJUPUT OILINACTIVE INGREDIENTJ3TO6BUQ372
CLOVE OILINACTIVE INGREDIENT578389D6D02

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52486-01352486-013-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAJUPUT OILJ3TO6BUQ37IACT
CLOVE OIL578389D6D0IACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOLL7T10EIP3AACTIB

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 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
3 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
44bd9411-0c67-1729-e054-00144ff88e880db4294b-4451-4063-a442-bbf3078bc8062016-12-28WarningsExact identifier
spl id: 44bd9411-0c67-1729-e054-00144ff88e88
spl set id: 0db4294b-4451-4063-a442-bbf3078bc806

Reported adverse events (FAERS/openFDA)#

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