FDA.reportPublic FDA data

TerraFreeze Pain Relief Cream

Manufacturer
Beyond Derma, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:10

Label at a glance#

ProductTerraFreeze Pain Relief
Active ingredientMENTHOL, METHYL SALICYLATE, HISTAMINE DIHYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of the muscles and joints associated with arhritis, simple backache, sprains, bruises and strains.

Dosage and administration

  Apply to affected area 3-4 times daily. Adults and children two-years of age or older:   Consult a physician Children under two-years of age:

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.00%

Methyl Salicylate 10.00%

Histamine DHCl 0.050%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of the muscles and joints associated with arhritis, simple backache, sprains, bruises and strains.

Warnings:

WARNINGS SECTION

  • For External use only
  • Keep out of reach of children. If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.  If product gets into eyes, rinse thoroughly with water
  • Do not bandage tightly

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Rash appears
  • If symptoms persist for more than seven days, discontinue use and consult physician

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  •   Apply to affected area 3-4 times daily. Adults and children two-years of age or older:
  •   Consult a physician Children under two-years of age:

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature with lid closed tightly.

Other Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, AScorbic Acid (Vitamin C), Bosewellia Serrata Extract, Bromelain, Butylene Glycol, C13-14 Isoparaffin, Chamomilla Recutta (Chamomile) Extract, Citric Acid, Curcuma Longa (Turmeric) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Laureth-7, magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Tricedeth-6, Zingiber Officinale (Ginger) Root Extract

Questions or Comments?

OTC - QUESTIONS SECTION

(support email address) or Call 1.855.977.0726

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1947261histamine dihydrochloride 0.050 % / menthol 10 % / methyl salicylate 10 % Topical CreamPSN2
1947261histamine dihydrochloride 0.5 MG/ML / menthol 100 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD2
1947261histamine dihydrochloride 0.050 % / menthol 10 % / methyl salicylate 10 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71805-855-00TerraFreeze Pain Relief57 g in 1 PACKAGECREAM572
71805-855-00TerraFreeze Pain Relief1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71805-855TERRAFREEZE PAIN RELIEF (MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE) CREAM [BEYOND DERMA, LLC]2Current NDC, Legacy NDC, 2 package rows20231112_81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71805-85571805-855-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
BROMELAINSU182GP2CF3IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TURMERIC856YO1Z64FIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
LICORICE61ZBX54883IACT
SUNFLOWER OIL3W1JG795YIIACT
LAURETH-7Z95S6G8201IACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
NIACIN2679MF687AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECETH-63T5PCR2H0CIACT
GINGERC5529G5JPQIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB

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
TerraFreeze Pain ReliefMENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDEBeyond Derma, LLC81dc70b3-7e93-4f9a-ae3a-b50bbfd1a6772023-11-11WarningsExact identifier
ndc (package): 71805-855-00
ndc (product): 71805-855
ndc11 (package): 71805085500
spl id: 09dc09a4-8c6f-1ab6-e063-6394a90a8b1d
spl set id: 81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677

Reported adverse events (FAERS/openFDA)#

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