Miel Rosada

Manufacturer
Dannso Corp./d.b.a. Essential Products | World Perfume, Inc
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:01

Label at a glance#

ProductMiel Rosada
Active ingredientSODIUM BORATE, GLYCERIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                      Purpose

SODIUM BORATE .............................. Antifungal

Glycerin ................................................. Moisturizer

OTC - PURPOSE SECTION

Use

May help aliviate mouth ulcers

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.

INDICATIONS & USAGE SECTION

Antifuncgal

For External Use Only

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the affected area
  • and dry thoroughly. Apply a thin layer 1 to 3 times daily.
  • May be covered with a sterile bandage, let dry first.
  • Children under 2 years should consult a physician.

WARNINGS SECTION

Warnings For external use only

Avoid Contact with eyes.

When using this product

  • do not use on irritated skin, in or near eyes or mocous membranes, on wounds or damaged skin, if prone to allergic reaction
  • Fatal if swallowed.

Stop use and ask a doctor if condition persists or gets worse

INACTIVE INGREDIENT SECTION

Inactive Ingredients Extract of Roses, Honey , FD&C red # 40, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70242-127-012025-01-30C16284748780-19d75b9d0-411a-f424-e053-dadaa90a57ceMiel Rosada
70242-127-012023-11-14C16284748780-19d75b9d0-411a-f424-e053-dadaa90a57ceMiel Rosada
70242-127-012020-01-31C16284748780-19d75b9d0-411a-f424-e053-dadaa90a57ceMiel Rosada

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70242-127-01Miel Rosada30 mL in 1 BOTTLE, PLASTICSOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70242-127MIEL ROSADA (SODIUM BORATE, GLYCERIN) SOLUTION [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]2Legacy NDC, 1 package rows20231115_362f20d7-3fd1-4e46-8c90-155457105ac3.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70242-12770242-127-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
1a368815-91d9-41ba-aa3e-809ee1b2e4ce362f20d7-3fd1-4e46-8c90-155457105ac32023-01-01WarningsExact identifier
spl id: 1a368815-91d9-41ba-aa3e-809ee1b2e4ce
spl set id: 362f20d7-3fd1-4e46-8c90-155457105ac3

Reported adverse events (FAERS/openFDA)#

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