thermal-AID

Manufacturer
Pacific Shore Holdings, Inc. | Filltech USA, LLC
Effective date
2019-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:27

Label at a glance#

Productthermal-AID Headache Relief
Active ingredientBRYONIA ALBA ROOT, TOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Indications and uses

External analgesic for temporary relief of headache and migraine pain.

Dosage and administration

Adults and children age 12 and older: Apply a small amount of cream to forehead and temples, and massage into skin. Use as needed and when headache pain flares up.

Storage and handling

Store at 68 to 77 degrees Fahrenheit.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Bryonia 6x HPUS 0.1%Muscle aches and stiffness
Rhus Toxicodendron 6x HPUS 0.1%Muscle pain and stiffness

Uses

INDICATIONS & USAGE SECTION

External analgesic for temporary relief of headache and migraine pain.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes and open wounds.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition persists for more than 7 days or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of ingestion, seek professional assistance or contact a poison control center.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children age 12 and older: Apply a small amount of cream to forehead and temples, and massage into skin. Use as needed and when headache pain flares up.

Other Information

STORAGE AND HANDLING SECTION

Store at 68 to 77 degrees Fahrenheit.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Steric Acid, Polysorbate 60, Cocos Nucifera (Coconut) Oil, Cetyl Alcohol, Cetearyl Alcohol, Propylene Glycol, Mineral Oil, Myristyl Myristate, Glycine Soja (Soybean) Oil, Sodium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Menthol, Tocopheryl Acetate, Squalene, Soluble Collagen, Hydrolyzed Elastin, Allium Sativum (Garlic) Bulb Extract, Glycerin, Caprylhydroxamic Acid, Benzyl Alcohol.

SPL UNCLASSIFIED SECTION

Distributed by:
Pacific Shore Holdings, Inc.
Chatsworth, CA 91311

PRINCIPAL DISPLAY PANEL - 57 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

thermal-AID ®

Headache Relief Cream
Fast, Safe, Powerful Relief You Can Count On

NET WT 2 OZ. (57g)

PRINCIPAL DISPLAY PANEL - 57 g Tube Label
PRINCIPAL DISPLAY PANEL - 57 g Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69314-201-422022-01-28C16284748780-1d6a99b39-4df0-a426-e053-dadaa90af4c2thermal-AID ® Headache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69314-201-42thermal-AID Headache Relief57 g in 1 TUBECREAM571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69314-201THERMAL-AID HEADACHE RELIEF (BRYONIA ALBA ROOT AND TOXICODENDRON PUBESCENS LEAF) CREAM [PACIFIC SHORE HOLDINGS, INC.]1Legacy NDC, 1 package rows20190905_c2a58b7e-0874-4445-a821-1926f6485f7e.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69314-20169314-201-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
1d848bbe-925e-47d4-aff6-9645df3e9fe0c2a58b7e-0874-4445-a821-1926f6485f7e2019-08-30WarningsExact identifier
spl id: 1d848bbe-925e-47d4-aff6-9645df3e9fe0
spl set id: c2a58b7e-0874-4445-a821-1926f6485f7e

Reported adverse events (FAERS/openFDA)#

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