FDA.reportPublic FDA data

Theriac Advanced Healing Ointment

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-10-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:35

Label at a glance#

ProductTheriac Advanced Healing
Active ingredientLANOLIN
Label structure10 sections

Indications and uses

Temporarily Protects Minor: cuts  scrapes burns

Dosage and administration

Apply as needed ot the affacted area and gently rub for 30 seconds  Product may be used with or without secondary dressing.

Storage and handling

Call 1-800-222-1087 Store at room temperature 68° - 77°F ( 20° - 25°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lanolin 35.08%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily Protects Minor:

  • cuts 
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

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 for more thna 7 days or clear up and occur again within a few days.

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed ot the affacted area and gently rub for 30 seconds 
  • Product may be used with or without secondary dressing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Althaea Officinalis Root Extract, Artemisia Vulgaris Extract, Beeswax, Extra Virgin Olea Europaea (Olive) Fruit Oil, Glycerin, Lobelia Inflata, Manuka Honey, Quercus Alba Bark Extract, Symphytum Officinale Rhizome/Root Extract , Triticum Vulgare (Wheat) Germ Oil

Questions or comments?

STORAGE AND HANDLING SECTION

Call 1-800-222-1087

Store at room temperature 68° - 77°F ( 20° - 25°C).

Theriac Advance Healing Ointment 0.5 oz Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THERIAC                                                       NDC 11527-325-33

Advanced Healing Ointment 

Lanolin 35.08% 

Skin Protectant

FREE FROM ANTIBIOTIC, PARABENS & PETROLEUM-BASED INGREDIENTS 

NET WT 0.5 OZ (15g)

Theriac Advance Healing Ointment 0.5 oz TubeTheriac Advance Healing Ointment 0.5 oz Tube

Theriac Advance Healing Ointment 0.5 OZ Carton 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THERIAC                         NDC 11527-325-33

Advance Healing Ointment 

Lanolin 35.08%

Skin Protectant 

FREE FROM ANTIBIOBTICS, PARABENS & PETROLEUM-BASED INGREDIENTS

NET WT 0.5 OZ (15g)

Theriac Advance Healing Ointment 0.5 OZ CartonTheriac Advance Healing Ointment 0.5 OZ Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2480889lanolin 35 % Topical OintmentPSN3
2480889lanolin 0.35 MG/MG Topical OintmentSCD3
2480889lanolin 35 % Topical OintmentSY3
2480889lanolin 35.08 % Topical OintmentSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-325-33Theriac Advanced Healing15 g in 1 TUBEOINTMENT153
11527-325-33Theriac Advanced Healing1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-325THERIAC ADVANCED HEALING (LANOLIN) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20231025_c780cd27-dc9e-45f3-97f0-e59b1b6b955a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11527-32511527-325-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
ARTEMISIA VULGARIS WHOLEJDR81QW9ZQIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
GLYCERINPDC6A3C0OXIACT
LOBELIA INFLATA WHOLE9PP1T3TC5UIACT
HONEYY9H1V576FHIACT
QUERCUS ALBA BARK93LP7Y8EGTIACT
SYMPHYTUM OFFICINALE WHOLEH8FJJ6KX5YIACT
WHEAT GERM OIL14C97E680PIACT

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
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
ndc (package): 11527-325-33
ndc (product): 11527-325
ndc11 (package): 11527032533
spl id: c7f30424-fc84-4781-a2bf-3291ede35271
spl set id: c780cd27-dc9e-45f3-97f0-e59b1b6b955a

Reported adverse events (FAERS/openFDA)#

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