Theresienol MD Skin Protectant

Manufacturer
Fordee Group, LLC
Effective date
2021-08-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:39:12

Label at a glance#

ProductTheresienol MD Skin Protectant
Active ingredientLANOLIN
Label structure15 sections

Storage and handling

Other information store between 46°-77°F (8°-25°C) use within 6 months of opening

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Lanolin 12.5%

OTC - PURPOSE SECTION

Purpose

Skin protectant

INDICATIONS & USAGE SECTION

Uses temporarily protects

  • minor cuts, scrapes and burns
  • chafed, chapped or cracked skin

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions apply as needed

STORAGE AND HANDLING SECTION

Other information

  • store between 46°-77°F (8°-25°C)
  • use within 6 months of opening

INACTIVE INGREDIENT SECTION

Inactive ingredients

Apple Fruit Extract, Chicken Fat Extract, Clarified Butter, Pentylene Glycol, Sea Onion Leaf Extract, Tocopherol, Tocopherol Acetate

SPL UNCLASSIFIED SECTION

Multi-purpose natural skin care serum with lanolin for all skin types, all ages & all stages.

Works naturally with your body.

  • Protects and helps relieve minor burns
  • Protects and helps relieve minor scrapes
  • Helps relieve & heals cracked or chapped skin
  • Soothes, hydrates & protects irritated skin
  • Natural ingredients

Exclusively distributed by:

4DG

1700 Post Oak Blvd.

2BLVD PLACE, Suite 600

Houston, TX 77056, USA

www.4DG.life

Made in Austria

SPL UNCLASSIFIED SECTION

Skin protectant drug product.

A drug product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theresienol MD

Multi-purpose

SKIN PROTECTANT+ with LANOLIN

for minor

BURNS+CUTS+SCRAPES

NATURAL SKIN SERUM

0.5 fl. oz. / 15ml

Riviera Skin Serum FinalRiviera Skin Serum Final

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72184-001THERESIENOL MD SKIN PROTECTANT (LANOLIN) LIQUID [FORDEE GROUP, LLC]3Legacy NDC20210802_6855c562-ecdb-5e82-e053-2a91aa0a2d40.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
72184-00172184-001-15, 72184-001-04, 72184-001-20, 72184-001-01

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
c88df38f-6f33-3e76-e053-2995a90a468f6855c562-ecdb-5e82-e053-2a91aa0a2d402021-08-02WarningsExact identifier
spl id: c88df38f-6f33-3e76-e053-2995a90a468f
spl set id: 6855c562-ecdb-5e82-e053-2a91aa0a2d40

Reported adverse events (FAERS/openFDA)#

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