Sore No More Warm Therapy Natural Pain Relieving Gel Canada

Manufacturer
SOMBRA COSMETICS INC.
Effective date
2023-03-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:54:24

Label at a glance#

ProductSORE NO MORE WARM THERAPY
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure9 sections

Indications and uses

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

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 3%, Camphor USP 3%

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

Warnings

WARNINGS SECTION

For external use only. Do not use on wounds or damaged skin. 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, 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

aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol, capsicum annuum fruit extract

Questions or Comments

OTC - QUESTIONS SECTION

1-800-225-3963

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
630714camphor 3 % / menthol 3 % Topical GelPSN5
630714camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical GelSCD5
630714camphor 3 % / menthol 3 % Topical GelSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-4040-22025-01-30C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-32025-01-30C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-42025-01-30C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-52025-01-30C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-22023-03-08C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-32023-03-08C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-42023-03-08C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-52023-03-08C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-22023-01-30C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-32023-01-30C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-42023-01-30C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-52023-01-30C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-22020-03-06C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-32020-03-06C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-42020-03-06C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-52020-03-06C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-22020-01-31C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-32020-01-31C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-42020-01-31C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada
61577-4040-52020-01-31C16284748780-19d75b9d0-f46f-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel Canada

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-4040-2SORE NO MORE WARM THERAPY907.2 g in 1 BOTTLE, PUMPGEL907.25
61577-4040-3SORE NO MORE WARM THERAPY226.8 g in 1 JARGEL226.85
61577-4040-4SORE NO MORE WARM THERAPY113.4 g in 1 JARGEL113.45
61577-4040-5SORE NO MORE WARM THERAPY85 g in 1 BOTTLE, PLASTICGEL855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-4040SORE NO MORE WARM THERAPY (MENTHOL AND CAMPHOR) GEL [SOMBRA COSMETICS INC.]5Legacy NDC, 4 package rows20230309_d2b7fc54-c765-406a-a876-e83f6cdf94d1.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-404061577-4040-2, 61577-4040-3, 61577-4040-4, 61577-4040-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
aff29efc-56b8-4501-861a-2366133e695fd2b7fc54-c765-406a-a876-e83f6cdf94d12023-03-08WarningsExact identifier
spl id: aff29efc-56b8-4501-861a-2366133e695f
spl set id: d2b7fc54-c765-406a-a876-e83f6cdf94d1

Reported adverse events (FAERS/openFDA)#

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