FDA.reportPublic FDA data

El Balsamo de Tigre

Manufacturer
Miramar Cosmetics, Inc DBA Miramar Lab
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:44

Label at a glance#

ProductEl Balsamo de Tigre
Active ingredientMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

*Helps relieve minor aches and pain of muscles, joints, strains, backache, sprains, and sport injuries.

Dosage and administration

Clean area before use. Adults & Children 12 years of age or older: Apply to affected area no more than 3 times daily. Temporary burning may be felt when applied, but disappears with continued use. Wash hands after used. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is noted within 1-2 weeks. Children under 12 years: Consult a Physician before use.

Storage and handling

Store at 15-25° C (59-77° F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 10%
Menthol 3.5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

*Helps relieve minor aches and pain of muscles, joints, strains, backache, sprains, and sport injuries.

Warnings:

WARNINGS SECTION

For external use only.

Do not Use:
• If allergic to salicylates (including aspirin) without consulting a physician.
• On open wounds, damage or irritated skin, immediately after or before taking a shower.

Stop use and ask a Doctor: If conditions worsen, symptoms persist or skin irritations occurs.

When using this product: Avoid contact with eyes, lips and any mucous membranes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed get medical help. Do not bandage.

Directions:

DOSAGE & ADMINISTRATION SECTION

Clean area before use.
Adults & Children 12 years of age or older: Apply to affected area no more than 3 times daily. Temporary burning may be felt when applied, but disappears with continued use.
Wash hands after used. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is noted within 1-2 weeks.

Children under 12 years: Consult a Physician before use.

Other Information:

STORAGE AND HANDLING SECTION

Store at 15-25° C (59-77° F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

White Petrolatum, Eucalyptus oil, Clove Oil, Dark Brown MX-486

SPL UNCLASSIFIED SECTION

MADE IN USA
SATISFACTION GUARANTEED QUALITY

*These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent any disease.

Distributed by:
OTC & Quality Distribution
Orlando, FL 32837

InfoLine:
1-877-325-7887

www.otcqualitydistribution.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Miramar-208Miramar-208

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2670391menthol 3.5 % / methyl salicylate 10 % Topical OintmentPSN2
2670391menthol 0.035 MG/MG / methyl salicylate 0.1 MG/MG Topical OintmentSCD2
2670391menthol 3.5 % / methyl salicylate 10 % Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79974-208-05El Balsamo de Tigre150 g in 1 JAROINTMENT1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79974-208EL BALSAMO DE TIGRE (METHYL SALICYLATE, MENTHOL) OINTMENT [MIRAMAR COSMETICS, INC DBA MIRAMAR LAB]21 package rows20250116_de245261-83a5-4aba-8d7e-470ff0cf845c.zip

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
79974-20879974-208-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
WHITE PETROLATUMB6E5W8RQJ4IACT
EUCALYPTUS OIL2R04ONI662IACT
CLOVE OIL578389D6D0IACT
D&C GREEN NO. 64QP5U84YF7IACT
D&C RED NO. 17ND733RX3JNIACT
D&C YELLOW NO. 1144F3HYL954IACT

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
7a6b6db6-a873-407f-b29e-47cc0c3bff8cde245261-83a5-4aba-8d7e-470ff0cf845c2025-01-13WarningsExact identifier
spl id: 7a6b6db6-a873-407f-b29e-47cc0c3bff8c
spl set id: de245261-83a5-4aba-8d7e-470ff0cf845c

Reported adverse events (FAERS/openFDA)#

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