FDA.reportPublic FDA data

Zpol ULTRA

Manufacturer
Laboratorios Zepol S.A.
Effective date
2025-03-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:22

Label at a glance#

ProductZpol ULTRA
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%Methyl Salicylate 10%

Purpose

OTC - PURPOSE SECTION

Active IngredientsPurpose
Menthol 2.84%Topical Analgesic
Methyl salicylate 18.24%Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Do not apply to wounds or damaged skin

Do not bandage tightly

Avoid contact with eyes

Do not use with a heating pad

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Do not use, consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store between 20-25°C (68-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, benzoic acid, cetearyl alcohol, cetearyl glucoside, pheonoxyethanol, stearic acid, water.

Questions?

OTC - QUESTIONS SECTION

Call toll free +506 (800)-937-6572 laboratorioszepol@zepolab.com

zpol ULTRA 1.02 Oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55715-008-01

zpol ULTRA

MUSCULAR Topical analgesic cream

Net wt. 1.02 Oz

ZepoLAB

Manufactured by

Laboratorios Zepol, S.A.

Curridabat, San José,

Costa Rica, 11801

Product of Costa Rica

IN COSTA RICA CALL FRO FREE 800-937-6572

(800-SZEPOLSA)

Regional Customer Service:

laboratorioszepol@zepolab.com

www.zepolab.com

Tamper Evident: Do not use if seal undercap is broken or missing

EXTERNAL USE/OVER THE COUNTER Zpol ULTRA Cream

is a medicated cream, due to its components and texture it is recommended for the relief of muscle pain, bumps, sprains and sports injuries. It also relieves arthritic and rheumatic pain.

EE

II

zpol ULTRA 2.08 Oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55715-008-02

zpol ULTRA

Topical analgesic cream

2.08 Oz

ZepoLAB

Zpol ULTRA 4.02 Oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55715-008-03

zpol ULTRA

Topical analgesic cream

4.02 Oz

ZepoLAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2684042menthol 2.84 % / methyl salicylate 18.24 % Topical CreamPSN3
2684042menthol 28.4 MG/ML / methyl salicylate 182 MG/ML Topical CreamSCD3
2684042menthol 2.84 % / methyl salicylate 18.24 % Topical CreamSY3

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55715-008-01Zpol ULTRA29 g in 1 BOTTLE, PLASTICCREAM293
55715-008-02Zpol ULTRA59 g in 1 BOTTLE, PLASTICCREAM593
55715-008-03Zpol ULTRA119 g in 1 BOTTLE, PLASTICCREAM1193

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55715-008ZPOL ULTRA (MENTHOL, METHYL SALICYLATE) CREAM [LABORATORIOS ZEPOL S.A.]3Current NDC, 3 package rows20250403_1a1433a6-8d04-96df-e063-6394a90a987b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55715-00855715-008-01, 55715-008-02, 55715-008-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN TRISTEARATE6LUM696811IACT
CARBOMER0A5MM307FCIACT
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-40 STEARATEECU18C66Q7IACT
CETEARETH-20YRC528SWUYIACT
EUCALYPTOLRV6J6604TKIACT
POLYSORBATE 207T1F30V5YHIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
TRIETHANOLAMINE9O3K93S3TKIACT
THYMOL3J50XA376EIACT
WATER059QF0KO0RIACT

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
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
ndc (package): 55715-008-03
ndc (package): 55715-008-02
ndc (package): 55715-008-01
ndc (product): 55715-008
ndc11 (package): 55715000802
ndc11 (package): 55715000803
ndc11 (package): 55715000801
spl id: 315525bd-c7a7-77aa-e063-6394a90a89bf
spl set id: 1a1433a6-8d04-96df-e063-6394a90a987b

Reported adverse events (FAERS/openFDA)#

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