FDA.reportPublic FDA data

Sore No More Warm Therapy Plus CBD 2000mg Natural Pain Relieving Gel

Manufacturer
SOMBRA COSMETICS INC.
Effective date
2022-05-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:44

Label at a glance#

ProductSore No More Warm Therapry Plus CBD 2000mg
Active ingredientCAMPHOR (SYNTHETIC)
Label structure9 sections

Indications and uses

TEMPORARILY RELIEVES MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH: SIMPLE BACKACHES

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 3%, CAMPHOR USP 3%

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: SIMPLE BACKACHES

WARNINGS SECTION

FOR EXTERNAL USE ONLY. DO NOT USE ON WOUNDS OR DAMAGED SKIN. WHEN USING THIS PRODUCTS: AVOID BANDAGING TIGHTLY, AVOID CONTACT WITH EYES, KEEP OUT OF REACH OF CHILDREN.

STOP USE AND ASK DOCTOR IF: CONDITION WORENS, SYMPTONS PERSIST FOR MORE THAN 7 DAYS, CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.

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, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) 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, cannabidiol, capsicum annuum fruit extract,

Question 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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-7012-52025-01-30C16284748780-12cef2736-a6b3-d83d-e063-dadaa90ab31fSore No More Warm Therapy Plus CBD 2000mg Natural Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-7012-5Sore No More Warm Therapry Plus CBD 2000mg113.4 g in 1 JARGEL113.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-7012SORE NO MORE WARM THERAPRY PLUS CBD 2000MG (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]3Legacy NDC, 1 package rows20220528_9c8383eb-b44a-4da1-9366-7d9fc1282f8e.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-701261577-7012-5

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 GALLATEGJW1U497V5IACT
water059QF0KO0RIACT
CAPSAICINS07O44R1ZMIACT
GRAPE SEED OIL930MLC8XGGIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
ROSA CENTIFOLIA FLOWER OILH32V31VMWYIACT
SODIUM CARBONATE45P3261C7TIACT
GLYCERINPDC6A3C0OXIACT
WITCH HAZEL101I4J0U34IACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT
ORANGE PEELTI9T76XD44IACT
CANNABIDIOL19GBJ60SN5IACT
MENTHOLL7T10EIP3AIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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
ae4a0051-51c5-405b-9ecb-f5d3bb3275129c8383eb-b44a-4da1-9366-7d9fc1282f8e2022-05-23WarningsExact identifier
spl id: ae4a0051-51c5-405b-9ecb-f5d3bb327512
spl set id: 9c8383eb-b44a-4da1-9366-7d9fc1282f8e

Reported adverse events (FAERS/openFDA)#

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