Indications and uses
Temporarily relieves minor aches and pains of muscles and joints associated with: strains, bruises, and sprains
SOMBRA PLUS CBD 2000MG COOL THERAPY
- Manufacturer
- Sombra Cosmetics Inc. | Sombra COSMETICS INC
- Effective date
- 2022-05-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:49:44
Label at a glance#
ProductSOMBRA PLUS CBD 2000MG COOL THERAPY
Active ingredientMENTHOL
Label structure8 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.
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: strains, bruises, and sprains
Warnings
For external use only. Do not use on wounds or damaged skin or with heat source. If you are pregnant or breastfeeding, consult a healthcare professional before use. When using this product: Avoid bandaging tightly, avoid contact with eyes, keep out of reach children
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, Cannabidiol (isolate), 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, Filipendula ulmaria (queen of the prairie) flower extract, yucca schidigera root extract,
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61577-7101-5 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7249-d83d-e063-dadaa90ab31f | Sombra Plux CBD 2000mg Cool Therapy |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61577-7101-5 | SOMBRA PLUS CBD 2000MG COOL THERAPY | 113.4 g in 1 JAR | GEL | 113.4 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61577-7101 | SOMBRA PLUS CBD 2000MG COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.] | 3 | Legacy NDC, 1 package rows | 20220528_97d9bdbb-66b2-48ba-ad51-36a5c50f5cb2.zip |
Products#
Every source-derived product name is available through these pages.
- SOMBRA PLUS CBD 2000MG 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
- LEMON OIL
- PHENOXYETHANOL
- CAPRYLYL GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61577-7101 | 61577-7101-5 |
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 |
|---|---|---|---|---|---|---|
| ca0b28e8-c25f-4414-9345-ea3c2dc0a436 | 97d9bdbb-66b2-48ba-ad51-36a5c50f5cb2 | 2022-05-24 | Warnings | ca0b28e8-c25f-4414-9345-ea3c2dc0a436 97d9bdbb-66b2-48ba-ad51-36a5c50f5cb2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.