FDA.reportPublic FDA data

PAIN BUST R II

Manufacturer
CCA Industries, Inc. | Suite K Value Added Services LLC
Effective date
2019-03-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:06

Label at a glance#

ProductPAIN BUST R II
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Dosage and administration

adults and children over 17 years  apply generously to affected area; massage into painful area until thoroughly absorbed into skin; repeat as necessary but no more than 4 times daily children 17 years or younger do not use without asking a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 12.00%

Methyl Salicylate 17.00%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with arthritis

Warnings

WARNINGS SECTION

For external use only

Allergy alert: Do not use if you are allergic to salicylates (including aspirin) unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Do not bandage tightly or use a heating pad
  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present
  • Irritation develops

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

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 17 years apply generously to affected area; massage into painful area until thoroughly absorbed into skin; repeat as necessary but no more than 4 times daily
children 17 years or youngerdo not use without asking a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ceteth-2, Cetyl Alcohol, DEA-Cetyl Phosphate, Emulsifying Wax, Glyceryl Stearate SE, PEG-40 Stearate, Stearic Acid, Stearyl Alcohol, Water (Aqua).

Other Information

SPL UNCLASSIFIED SECTION

Store in a cool palce

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-595-6230

Report any issues associated with this product to the telephone number or address listed on this package.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterPackage1OuterPackage1OuterPackage2OuterPackage2OuterPackage3OuterPackage3OuterPackage4OuterPackage4OuterPackage5OuterPackage5PainBustRTubePainBustRTube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259102menthol 12 % / methyl salicylate 17 % Topical CreamPSN3
259102menthol 120 MG/ML / methyl salicylate 170 MG/ML Topical CreamSCD3
259102menthol 12 % / methyl salicylate 17 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61543-3130-32024-01-30C16284748780-11030e365-34cf-111a-e063-dadaa90a10e2PAIN BUST R II

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-3130-3PAIN BUST R II1 in 1 CARTONCREAM13
61543-3130-3PAIN BUST R II85 g in 1 JARCREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-3130PAIN BUST R II (MENTHOL, METHYL SALICYLATE) CREAM [CCA INDUSTRIES, INC.]3Legacy NDC, 2 package rows20190409_64c97569-0485-4136-8fe7-8be4babd8973.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
MENTHOLACTIVE MOIETYL7T10EIP3A1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022Y1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61543-313061543-3130-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETETH-27H8VAM7778IACT
DIETHANOLAMINE CETYL PHOSPHATE4UG0316V9SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-40 STEARATEECU18C66Q7IACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

Source Document#

Source XML · Source PDF

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
84b64407-c9d7-4c60-e053-2991aa0afaac64c97569-0485-4136-8fe7-8be4babd89732019-03-22WarningsExact identifier
spl id: 84b64407-c9d7-4c60-e053-2991aa0afaac
spl set id: 64c97569-0485-4136-8fe7-8be4babd8973

Reported adverse events (FAERS/openFDA)#

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