FDA.reportPublic FDA data

Herbal Freeze Pain Relieving Gel

Manufacturer
SOMBRA COSMETICS INC.
Effective date
2023-03-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:25

Label at a glance#

ProductHERBAL FREEZE
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches, strains, bruises, and sprains

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP %

Purpose

OTC - PURPOSE SECTION

Purpose
External Analgesic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches, strains, bruises, and sprains

Warnings

WARNINGS SECTION

For external use only. Do not use on wounds or damaged skin or with a heat source. If pregnant or breastfeeding, consult a healthcare professional before use.When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Ethyl Alcohol, Arnica Montana (Arnica) Flower Extract, Populus Balsimafora (Balsam Poplar) Bud Extract, Hypericum Perforatum (St. John's Wort) Flower Extract, Glycerin

Questions or Comments

OTC - QUESTIONS SECTION

1-877-239-4667

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259550menthol 6 % Topical SprayPSN3
259550menthol 60 MG/ML Topical SpraySCD3
259550menthol 6 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-3385-22025-01-30C16284748780-1f386c64a-0cd1-0266-e053-dadaa90a7c1aHerbal Freeze Pain Relieving Gel
61577-3385-32025-01-30C16284748780-1f386c64a-0cd1-0266-e053-dadaa90a7c1aHerbal Freeze Pain Relieving Gel
61577-3385-22023-03-08C16284748780-1f386c64a-0cd1-0266-e053-dadaa90a7c1aHerbal Freeze Pain Relieving Gel
61577-3385-32023-03-08C16284748780-1f386c64a-0cd1-0266-e053-dadaa90a7c1aHerbal Freeze Pain Relieving Gel
61577-3385-22023-01-30C16284748780-1f386c64a-0cd1-0266-e053-dadaa90a7c1aHerbal Freeze Pain Relieving Gel
61577-3385-32023-01-30C16284748780-1f386c64a-0cd1-0266-e053-dadaa90a7c1aHerbal Freeze Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-3385-2HERBAL FREEZE85 g in 1 BOTTLE, SPRAYSPRAY853
61577-3385-3HERBAL FREEZE113.4 g in 1 BOTTLE, SPRAYSPRAY113.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-3385HERBAL FREEZE (MENTHOL) SPRAY [SOMBRA COSMETICS INC.]3Legacy NDC, 2 package rows20230309_e25838f0-c7e2-4504-ab53-58097cf6605a.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-338561577-3385-3, 61577-3385-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
POPULUS BALSAMIFERA LEAF BUD9CQ6C00G3CIACT
HYPERICUM PERFORATUM FLOWERA6V4CUE7PVIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB

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
3062ed70-db5e-427b-81e4-6379beedf4a4e25838f0-c7e2-4504-ab53-58097cf6605a2023-03-08WarningsExact identifier
spl id: 3062ed70-db5e-427b-81e4-6379beedf4a4
spl set id: e25838f0-c7e2-4504-ab53-58097cf6605a

Reported adverse events (FAERS/openFDA)#

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