Arumacil Protectant Cold Sore Ointment

Manufacturer
Hyatt Life Sciences, Inc.
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:56:58

Label at a glance#

ProductArumacil Protectant Cold Sore
Active ingredientDIMETHICONE, PETROLATUM
Label structure6 sections

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredients 

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.1%

Petrolatum 92.8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

  • relieves dryness and softens cold sores and fever blisters

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds 
  • animal bites
  • serious burns

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

  • apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arum Palaestinum, Beta-Sitosterol, Peganum Harmala, Turmeric, Vanillin, Vitamin C

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72933-006-012025-11-24C16284748780-11030e365-6358-111a-e063-dadaa90a10e2Arumacil Protectant Cold Sore Ointment
72933-006-012024-01-30C16284748780-11030e365-6358-111a-e063-dadaa90a10e2Arumacil Protectant Cold Sore Ointment

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72933-006ARUMACIL PROTECTANT COLD SORE (DIMETHICONE, PETROLATUM) OINTMENT [HYATT LIFE SCIENCES, INC.]1Legacy NDC20210113_b7b38985-a96b-22c5-e053-2995a90a3f9c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72933-00672933-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
09ccb37b-78de-b510-e063-6294a90a48d5b7b38985-a96b-22c5-e053-2995a90a3f9c2023-11-10WarningsExact identifier
spl set id: b7b38985-a96b-22c5-e053-2995a90a3f9c

Reported adverse events (FAERS/openFDA)#

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