FDA.reportPublic FDA data

NeuroFreeze

Manufacturer
Blue Heron Pharmaceuticals, LLC | SOMBRA COSMETICS INC.
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:48:55

Label at a glance#

ProductNeuroFreeze
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

Temporary relief of minor aches and pains of muscles and joints associated with: Strains Bruises Sprains

Dosage and administration

Apply to affected area not more then 3 to 4 times daily. Rub thoroughly until gel is absorbed. For children under 2 years of age: Ask a doctor.

Storage and handling

Store at 68-77℉ (20-25℃) - Room Temperature Do not exceed 100 oF (38 o C)

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 6%

Purposes:

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains of muscles and joints associated with:

  • Strains
  • Bruises
  • Sprains

Directions:Adults and children 2 years of age and older:

DOSAGE & ADMINISTRATION SECTION

Apply to affected area not more then 3 to 4 times daily.
Rub thoroughly until gel is absorbed.
For children under 2 years of age: Ask a doctor.

Warnings:

WARNINGS SECTION

For external use ONLY. 

Do not use on wounds or damaged skin or with a heat source. If pregnant or breastfeeding, ask a healthcare professional before use.

When using this product:

  • Avoid bandaging tightly
  • Avoid contact with eyes
  • Keep out of the reach of children

Stop use and ask doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms persist for more than 7 days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

Storage:

STORAGE AND HANDLING SECTION

  • Store at 68-77℉ (20-25℃) - Room Temperature
  • Do not exceed 100 oF (38 oC)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Carbomer, Citrus Grandis (Grapefruit) Seed Extract, Citrus Limon (Lemon) Peel Oil, Decyl Glucoside, Filipendula Ulmaria (Queen of the Prairie) Flower Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate, Yucca Schidigera Stem Extract.

SPL UNCLASSIFIED SECTION

Manufactured for:
Blue Heron Pharmaceuticals, LLC
2831 Allegra Way, Suite 218
Lutz, FL 33559

Questions or concerns call 813-380-0271

www.blueheronpharma.com

Packaging:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeuroFreezeNeuroFreeze

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415976menthol 6 % Topical GelPSN1
415976menthol 0.06 MG/MG Topical GelSCD1
415976menthol 6 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 12885622-0511-85NeuroFreeze Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85622-511-85NeuroFreeze85 g in 1 BOTTLE, WITH APPLICATORLIQUID851

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85622-511-85GM - Gram85622-511e05d06d0-0fe7-4055-9e23-4acd788688be12026-04-20

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85622-51185622-511-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER0A5MM307FCIACT
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OILAKN3KSD11BIACT
CITRUS LIMON (LEMON) PEEL OILI9GRO824LLIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
GLYCERINPDC6A3C0OXIACT
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
SODIUM CARBONATE45P3261C7TIACT
YUCCA SCHIDIGERA STEMN59C6T6D72IACT

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
NeuroFreezeMENTHOLBlue Heron Pharmaceuticals, LLCbb8aba0a-2378-4eb5-b51e-22957586480b2026-02-23WarningsExact identifier
ndc (package): 85622-511-85
ndc (product): 85622-511
ndc11 (package): 85622051185
spl id: 53f232d7-6507-406c-8a2c-e702350592c8
spl set id: bb8aba0a-2378-4eb5-b51e-22957586480b

Reported adverse events (FAERS/openFDA)#

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