Indications and uses
Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches
Sore No More Cool Therapy Natural Pain Relieving Gel
- Manufacturer
- SOMBRA COSMETICS INC.
- Effective date
- 2025-05-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:37
Label at a glance#
ProductSORE NO MORE 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, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) 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
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 |
|---|---|---|---|---|---|---|
| 61577-3235-1 | SORE NO MORE COOL THERAPY | 226.8 g in 1 JAR | GEL | 226.8 | 12 | |
| 61577-3235-2 | SORE NO MORE COOL THERAPY | 907.2 g in 1 BOTTLE, PUMP | GEL | 907.2 | 12 | |
| 61577-3235-4 | SORE NO MORE COOL THERAPY | 113.4 g in 1 JAR | GEL | 113.4 | 12 | |
| 61577-3235-5 | SORE NO MORE COOL THERAPY | 85 g in 1 BOTTLE, PLASTIC | GEL | 85 | 12 | |
| 61577-3235-6 | SORE NO MORE COOL THERAPY | 113.4 g in 1 TUBE | GEL | 113.4 | 12 | |
| 61577-3235-7 | SORE NO MORE COOL THERAPY | 56.7 g in 1 JAR | GEL | 56.7 | 12 | |
| 61577-3235-8 | SORE NO MORE COOL THERAPY | 28.3 g in 1 JAR | GEL | 28.3 | 12 | |
| 61577-3235-9 | SORE NO MORE COOL THERAPY | 5 g in 1 POUCH | GEL | 5 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61577-3235 | SORE NO MORE COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.] | 12 | Current NDC, Legacy NDC, 8 package rows | 20250529_9aa1f0ac-3baf-4e45-9e3a-c28a99b22909.zip |
Products#
Every source-derived product name is available through these pages.
- SORE NO MORE 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
- ORANGE PEEL
- LEMON OIL
- PHENOXYETHANOL
- CAPRYLYL GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61577-3235 | 61577-3235-2, 61577-3235-8, 61577-3235-1, 61577-3235-4, 61577-3235-5, 61577-3235-6, 61577-3235-7, 61577-3235-9 |
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 |
|---|---|---|---|---|---|---|
| SORE NO MORE COOL THERAPY | MENTHOL | SOMBRA COSMETICS INC. | 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | 2025-05-12 | Warnings | 61577-3235-9 61577-3235-7 61577-3235-5 61577-3235-4 61577-3235-2 61577-3235-1 61577-3235-6 61577-3235-8 61577-3235 61577323505 61577323506 61577323501 61577323507 61577323502 61577323509 61577323508 61577323504 3622f4f5-48bf-9035-e063-6294a90afac2 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.