FDA.reportPublic FDA data

Soothe

Manufacturer
Clay Therapy
Effective date
2022-02-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:48:15

Label at a glance#

ProductSoothe
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Mentha Arvensis Leaf Essential Oil, Helianthus Annuus (Sunflower) Seed Oil, Arnica Montana Flower Extract, Canadian Colloidal Clay, Sodium Carbomer, Caprylyl Glycol, Phenoxyethanol, Citrus Limon (Lemon) Peel Essential Oil, Rosmarinus Officinalis (Rosemary) Leaf Essential Oil, Eucalyptus Globulus Leaf Essential Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Pine (Pinus sylvestris) Essential Oil, Cinnamomum Camphora (Camphor) Bark Essential Oil, Polysorbate 80

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5%

OTC - PURPOSE SECTION

Topical Analgesic

WARNINGS SECTION

For external use only. Use only as directed.

Stop use and ask doctor if - Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

When using this product - Avoid contact with eyes - Do not apply to wounds or damaged skin - Do not bandage tightly

Flammable - Keep away from fire or flame.

If pregnant or breastfeeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SootheSoothe

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291226menthol 2.5 % Topical CreamPSN6
1291226menthol 25 MG/ML Topical CreamSCD6
1291226menthol 2.5 % Topical CreamSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81771-7001-12024-01-30C16284748780-11030e365-1f22-111a-e063-dadaa90a10e2c2b427c0-9612-7153-e053-2995a90aa6d0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81771-7001-1Soothe60 mL in 1 TUBECREAM606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81771-7001SOOTHE (MENTHOL) CREAM [CLAY THERAPY]6Legacy NDC, 1 package rows20220215_c2b427c0-9612-7153-e053-2995a90aa6d0.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
81771-700181771-7001-1

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
WATER059QF0KO0RIACT
PINUS SYLVESTRIS WHOLEVP00HZL9ICIACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRUS LIMON FRUIT OIL0HNC1J1YEDIACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CINNAMOMUM CAMPHORA LEAFY TWIG6RGO3JFT61IACT
POLYSORBATE 806OZP39ZG8HIACT
MENTHOLL7T10EIP3AACTIB
ROSMARINUS OFFICINALIS FLOWERING TOP OILOXN0D3N28LIACT
GLYCERINPDC6A3C0OXIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
BENTONITEA3N5ZCN45CIACT

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
d8005abc-2f81-2d28-e053-2a95a90a45fec2b427c0-9612-7153-e053-2995a90aa6d02022-02-14WarningsExact identifier
spl id: d8005abc-2f81-2d28-e053-2a95a90a45fe
spl set id: c2b427c0-9612-7153-e053-2995a90aa6d0

Reported adverse events (FAERS/openFDA)#

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