FDA.reportPublic FDA data

Sombra Plus CBD 500MG Cool Therapy

Manufacturer
SOMBRA COSMETICS INC. | SOMBRA COSMETICS INC
Effective date
2020-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:07

Label at a glance#

ProductSombra Plus CBD 500MG Cool Therapy
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: strains, bruises, and sprains

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 6%

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: strains, bruises, and sprains

Warnings

WARNINGS SECTION

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

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, 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,

Questions or Comments

OTC - QUESTIONS SECTION

1-800-225-3963

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-7500-22024-01-30C16284748780-11030e365-5c79-111a-e063-dadaa90a10e2Sombra Plus CBD 500MG Cool Therapy
61577-7500-42024-01-30C16284748780-11030e365-5c79-111a-e063-dadaa90a10e2Sombra Plus CBD 500MG Cool Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-7500-2Sombra Plus CBD 500MG Cool Therapy56.7 g in 1 JARGEL56.71
61577-7500-4Sombra Plus CBD 500MG Cool Therapy113.4 g in 1 JARGEL113.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-7500SOMBRA PLUS CBD 500MG COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1Legacy NDC, 2 package rows20201106_d2695a6f-dc89-4173-b34c-ca1be89efe01.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-750061577-7500-2, 61577-7500-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
WATER059QF0KO0RIACT
GRAPEFRUIT SEED OIL598D944HOLIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
ROSA CENTIFOLIA FLOWER OILH32V31VMWYIACT
SODIUM CARBONATE45P3261C7TIACT
GLYCERINPDC6A3C0OXIACT
WITCH HAZEL101I4J0U34IACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT
LEMON OILI9GRO824LLIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CANNABIDIOL19GBJ60SN5IACT
MENTHOLL7T10EIP3AACTIB

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
f630c23a-5a68-466b-badd-fa8770c3d2e2d2695a6f-dc89-4173-b34c-ca1be89efe012020-10-30WarningsExact identifier
spl id: f630c23a-5a68-466b-badd-fa8770c3d2e2
spl set id: d2695a6f-dc89-4173-b34c-ca1be89efe01

Reported adverse events (FAERS/openFDA)#

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