Soothe

Manufacturer
La Mend, Inc.
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:17:21

Label at a glance#

ProductSoothe
Active ingredientCAPSAICIN, MENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains.

Dosage and administration

Adults over 18 years: • use one patch. carefully remove the backing film and apply to the affected area not more than 3 to 4 times daily • each patch can be worn up to 12 hours • children under 18 years of age: consult a doctor

Storage and handling

• store in a cool, dry place • reseal the envelope by squeezing seal together

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.25%
Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache • arthritis • strains • bruises • sprains.

Warnings

WARNINGS SECTION

For external use only.

When using this product

• avoid contact with the eyes and other mucous membranes

• do not apply to wounds or damaged skin

• do not bandage tightly • use only as directed

Do not use• more than one patch at a time

• at the same time as other topical analgesics

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

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults over 18 years:

• use one patch. carefully remove the backing film and apply to the affected area not more than 3 to 4 times daily

• each patch can be worn up to 12 hours

• children under 18 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

• store in a cool, dry place

• reseal the envelope by squeezing seal together

Inactive ingredients

INACTIVE INGREDIENT SECTION

bentonite, ethylhexylacrylate, methacrylic acid, sodium stearate

Questions or comments?

OTC - QUESTIONS SECTION

310.909.8407 llamend.com

You may also report serious side effects to this phone number .

SPL UNCLASSIFIED SECTION

Temporarily soothe your pain. A topical patch made to alleviate mild to moderate discomfort in muscles and joints.
Let’s get you moving again!

Distributed by La Mend

PO Box 946

Chattanooga, TN 37401

Made in the USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SootheSoothe

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72587-111-222023-12-22C16284748780-1f386c649-a7ca-0266-e053-dadaa90a7c1aSoothe
72587-111-222023-01-30C16284748780-1f386c649-a7ca-0266-e053-dadaa90a7c1aSoothe

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72587-11172587-111-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
0cfc848e-8d8e-5d64-e063-6394a90a920a3e9f3240-0447-43fd-9de1-3066f5a5aecd2023-12-20WarningsExact identifier
spl id: 0cfc848e-8d8e-5d64-e063-6394a90a920a
spl set id: 3e9f3240-0447-43fd-9de1-3066f5a5aecd

Reported adverse events (FAERS/openFDA)#

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