Indications and uses
Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches
Sombra Cool Therapy Natural Pain Relieving Gel Canada
- Manufacturer
- SOMBRA COSMETICS INC.
- Effective date
- 2023-03-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 18
- Source
- full-release
- Hydrated at
- 2026-05-31 23:54:21
Label at a glance#
ProductSOMBRA COOL THERAPY
Active ingredientMENTHOL
Label structure9 sections
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.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Menthol USP 6%
Purpose
Purpose
External Analgesic
Keep out of reach of children
Keep out of reach of children
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches
Warnings
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
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
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, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf
Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate,
Spiraea Ulmaria Flower (Queen of the Prairie) Extract, Yucca Schidigera Root Extract.
Questions or Comments
1-800-225-3963
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61577-4030-1 | SOMBRA COOL THERAPY | 3628.7 g in 1 BOTTLE, PUMP | GEL | 3628.7 | 18 | |
| 61577-4030-2 | SOMBRA COOL THERAPY | 907.2 g in 1 BOTTLE, PUMP | GEL | 907.2 | 18 | |
| 61577-4030-3 | SOMBRA COOL THERAPY | 226.8 g in 1 JAR | GEL | 226.8 | 18 | |
| 61577-4030-4 | SOMBRA COOL THERAPY | 113.4 g in 1 JAR | GEL | 113.4 | 18 | |
| 61577-4030-5 | SOMBRA COOL THERAPY | 85 g in 1 BOTTLE, PLASTIC | GEL | 85 | 18 | |
| 61577-4030-6 | SOMBRA COOL THERAPY | 5 g in 1 POUCH | GEL | 5 | 18 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61577-4030 | SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.] | 18 | Legacy NDC, 6 package rows | 20230306_a2d403f7-aad0-4692-a36f-ee25a84a013f.zip |
Products#
Every source-derived product name is available through these pages.
- SOMBRA COOL THERAPY
- MENTHOL
- ALOE VERA LEAF
- CARBOMER HOMOPOLYMER TYPE C
- DECYL GLUCOSIDE
- WATER
- GRAPEFRUIT SEED OIL
- GREEN TEA LEAF
- FILIPENDULA ULMARIA FLOWER
- ROSA CENTIFOLIA FLOWER OIL
- SODIUM CARBONATE
- GLYCERIN
- WITCH HAZEL
- YUCCA SCHIDIGERA ROOT
- PHENOXYETHANOL
- CAPRYLYL GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61577-4030 | 61577-4030-1, 61577-4030-6, 61577-4030-2, 61577-4030-3, 61577-4030-4, 61577-4030-5 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 683bcc7b-edda-4eca-8eb1-6e24db6994ee | a2d403f7-aad0-4692-a36f-ee25a84a013f | 2023-03-03 | Warnings | 683bcc7b-edda-4eca-8eb1-6e24db6994ee a2d403f7-aad0-4692-a36f-ee25a84a013f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.