Pain Relieving Balm

Manufacturer
TopCo | Product Quest mfg
Effective date
2018-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:24

Label at a glance#

ProductPain Relieving Balm
Active ingredientMenthol, Methyl Salicylate
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                        Purpose
Menthol 7.6%.............................................Topical Analgesic
Methyl Salicylate 29%.................................Topical Analgesic

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor pain associated with:
• arthritis • simple backache • muscle strains • bruises
• muscle sprains • cramps

WARNINGS SECTION

Warnings
For external use only
Allergy Alert: If prone to allergic reaction from aspirin or
salicylates, consult a doctor before use.
When using this product • use only as directed • avoid
contact with eyes or mucous membranes • do not bandage
tightly or use with a heating pad • do not apply to wounds or
damaged skin
Stop use and ask doctor if • condition worsens • redness
is present • irritation develops • symptoms persist for more
than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding, 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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and children over 12 years: • apply generously to
affected area • massage into painful area until
thoroughly absorbed into skin • repeat as
necessary, but not more than 4 times daily.
Children under 12 years: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients
Paraffin, White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2049867menthol 7.6 % / methyl salicylate 29 % Topical SolutionPSN1
2049867menthol 76 MG/ML / methyl salicylate 290 MG/ML Topical SolutionSCD1
2049867menthol 7.6 % / methyl salicylate 29 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800360952GTIN-13: 0036800360952
EAN-13: 0036800360952
GTIN-12: 036800360952
UPC-A: 036800360952
GTIN storage (14 digits): 00036800360952
label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-738-042020-01-31C16284748780-19d75b9d0-634c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-738-04Pain Relieving Balm99.2 g in 1 PACKAGELIQUID99.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-738PAIN RELIEVING BALM (MENTHOL, METHYL SALICYLATE) LIQUID [TOPCO]1Legacy NDC, 1 package rows20180724_031eeb47-9a41-4915-a100-531ca0e88abe.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-73836800-738-04

Ingredients#

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

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

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
f4f67326-e7e8-4193-840c-f7fdb2f4eccb031eeb47-9a41-4915-a100-531ca0e88abe2018-07-24WarningsExact identifier
spl id: f4f67326-e7e8-4193-840c-f7fdb2f4eccb
spl set id: 031eeb47-9a41-4915-a100-531ca0e88abe

Reported adverse events (FAERS/openFDA)#

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