Indications and uses
Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains
321 Cool Pain Relief
- Manufacturer
- SOMBRA COSMETICS INC.
- Effective date
- 2026-04-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- full-release
- Hydrated at
- 2026-06-01 01:54:27
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: simple backaches, strains, bruises, and sprains
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 (meadowsweet) 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
321 CPR 3oz roll-on
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  128.pl/1VnTe | 321 CPR 3oz roll-on.jpg |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61577-3103-1 | SOMBRA COOL THERAPY | 85.05 g in 1 TUBE | GEL | 85.05 | 12 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| DECYL GLUCOSIDE | INACTIVE INGREDIENT | Z17H97EA6Y | 1 | |
| FILIPENDULA ULMARIA FLOWER | INACTIVE INGREDIENT | 06L18L32G6 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GRAPEFRUIT SEED OIL | INACTIVE INGREDIENT | 598D944HOL | 1 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| LEMON PEEL | INACTIVE INGREDIENT | 72O054U628 | 1 | |
| ROSA CENTIFOLIA FLOWER OIL | INACTIVE INGREDIENT | H32V31VMWY | 1 | |
| SODIUM HYDROXYMETHYLGLYCINATE | INACTIVE INGREDIENT | DIG6BWZ9XT | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| WITCH HAZEL | INACTIVE INGREDIENT | 101I4J0U34 | 1 | |
| YUCCA SCHIDIGERA ROOT | INACTIVE INGREDIENT | E2H9ET15AT | 1 |
Products#
Every source-derived product name is available through these pages.
- SOMBRA COOL THERAPY
- MENTHOL
- CARBOMER HOMOPOLYMER TYPE C
- DECYL GLUCOSIDE
- WATER
- GRAPEFRUIT SEED OIL
- GREEN TEA LEAF
- FILIPENDULA ULMARIA FLOWER
- ALOE VERA LEAF
- ROSA CENTIFOLIA FLOWER OIL
- SODIUM CARBONATE
- GLYCERIN
- WITCH HAZEL
- YUCCA SCHIDIGERA ROOT
- LEMON OIL
- PHENOXYETHANOL
- CAPRYLYL GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61577-3103 | 61577-3103-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 11 | 2026-03-26 | monthly-update | 2026-06-03 17:59:02 |
| 9 | 2026-02-25 | monthly-update | 2026-06-03 17:56:46 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| CARBOMER HOMOPOLYMER TYPE C | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TOPICAL | 85 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| CARBOMER HOMOPOLYMER TYPE C | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TOPICAL | 85 mg |
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 |
|---|---|---|---|---|---|---|
| SOMBRA COOL THERAPY | MENTHOL | SOMBRA COSMETICS INC. | 87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3 | 2026-04-21 | Warnings | 61577-3103-1 61577-3103 61577310301 4ffb85fd-c60e-3f70-e063-6294a90a6fdc 87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.