FDA.reportPublic FDA data

elp essential MANTECA DE UBRE

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 00:52:43

Label at a glance#

Productelp essential MANTECA DE UBRE
Active ingredientMETHYL SALICYLATE, CAMPHOR (NATURAL)
Label structure10 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

Dosage and administration

Wash the area with mild soap and warm water, rinse thoroughly. Apply generously and gently massage the affected area not more than 1 to 4 times daily. For Adults and Children 12 years of age and older. Children under 12 years of age or younger, ask a doctor.

Storage and handling

Tamper Evident Feature Do not use if seal under cap is torn, broken or missing. Store at 15° to 25° C (59° to 77° F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 10%

Camphor 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

Warnings

WARNINGS SECTION

For external use only • Avoid contact with eyes • Avoid mucous membranes

Do Not Use
In open wounds or damaged skin, with a heating pad, or with a tight bandage.

Stop use and Ask the doctor if.
You are allergic to Salicylate or any of this product's inactive ingredients, symptoms persist for more than seven days, redness is present or excessive irritation on the skin develops.

If pregnant or breast feeding. Contact a physician before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wash the area with mild soap and warm water, rinse thoroughly. Apply generously and gently massage the affected area not more than 1 to 4 times daily. For Adults and Children 12 years of age and older. Children under 12 years of age or younger, ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

Tamper Evident Feature Do not use if seal under cap is torn, broken or missing. Store at 15° to 25° C (59° to 77° F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Snow White Petrolatum, Tea Tree Oil, Eucalyptus Oil, Menthol, D&C Yellow.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 786 6469178 Weekdays from 9:30 Am to 4:30 Pm Eastern time.

SPL UNCLASSIFIED SECTION

UDDER BALM

EXTRA STRENGTH FORMULA

ANALGESIC OINTMENT

Distributed by essential products Miami, FL, 33012

Made In U.S.A.

Essentialproductsusa.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Udderbalm1Udderbalm1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2668189camphor 4 % / methyl salicylate 10 % Topical OintmentPSN2
2668189camphor 0.04 MG/MG / methyl salicylate 0.1 MG/MG Topical OintmentSCD2
2668189camphor 4 % / methyl salicylate 10 % Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79974-210-04elp essential MANTECA DE UBRE113 g in 1 TUBEOINTMENT1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79974-210ELP ESSENTIAL MANTECA DE UBRE (METHYL SALICYLATE, CAMPHOR) OINTMENT [MIRAMAR COSMETICS, INC DBA MIRAMAR LAB]2Current NDC, 1 package rows20250116_c3964dfe-17fe-4d89-a4c4-cf500f982259.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79974-21079974-210-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
WHITE PETROLATUMB6E5W8RQJ4IACT
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
D&C YELLOW NO. 1035SW5USQ3GIACT

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
elp essential MANTECA DE UBREMETHYL SALICYLATE, CAMPHORMiramar Cosmetics, Inc DBA Miramar Labc3964dfe-17fe-4d89-a4c4-cf500f9822592025-01-13WarningsExact identifier
ndc (package): 79974-210-04
ndc (product): 79974-210
ndc11 (package): 79974021004
spl id: 02446f40-f7ae-44c2-94ba-c4bc78909282
spl set id: c3964dfe-17fe-4d89-a4c4-cf500f982259

Reported adverse events (FAERS/openFDA)#

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