Balsamo de Vaca Mascura

Manufacturer
Menper Distributors Inc. | Rnv LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:08:14

Label at a glance#

ProductBalsamo de Vaca Mascura
Active ingredientMETHYL SALICYLATE
Label structure15 sections

Dosage and administration

Use only as directed  adults and children 12 years and older apply to affected area not more tha 3 to 4 times daily children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose
Methyl Salicylate 10.5 % ............................................External Analgesic

OTC - PURPOSE SECTION

Purpose

External Analgesic

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damage skin
  • with a heating pad
  • on a child under 12 years of age 
  • over extensive areas of the body
  • on irritated skin
  • woth a bandage

Ask doctor before use if you have 

OTC - ASK DOCTOR SECTION

redness over the affected area 

When using this product 

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage

Stop use and ask a doctor if 

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days 
  • symptoms clear up and occur again within a few days 
  • excessive skin irritation occurs

if pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use 

keep out of reach of children to avoid accidental poisoning.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Directions 

DOSAGE & ADMINISTRATION SECTION

  • Use only as directed 
  • adults and children 12 years and older apply to affected area not more tha 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 15° to 25° C (59° to 77° F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Camphor, D&C yellow 10#, menthol, methylparaben, paraffin wax, propylparaben, white petrolatum.

Questions?

OTC - QUESTIONS SECTION

call 1-800-60-5223 M-F 9 AM to 4 PM Eastern

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BalsamoVacaBalsamoVaca

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101920methyl salicylate 10.5 % Topical OintmentPSN3
1101920methyl salicylate 0.105 MG/MG Topical OintmentSCD3
1101920methyl salicylate 10.5 % Topical OintmentSY3

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
53145-403-032023-07-28C16284748780-10191ceaa-669b-198a-e063-dbdaa90aec3eBalsamo de Vaca Mascura

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-403-03Balsamo de Vaca Mascura90 g in 1 CANISTEROINTMENT903

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
53145-40353145-403-03

Ingredients#

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

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

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
Balsamo de Vaca MascuraMETHYL SALICYLATEMenper Distributors Inc.321b6f1f-c802-4b96-99d3-e77217da11a32025-07-22WarningsExact identifier
ndc (package): 53145-403-03
ndc (product): 53145-403
ndc11 (package): 53145040303
spl id: 3a8b300e-2dc0-3b7d-e063-6294a90a79de
spl set id: 321b6f1f-c802-4b96-99d3-e77217da11a3

Reported adverse events (FAERS/openFDA)#

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