Red hot ointment

Manufacturer
The Hygenic Company, LLC
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:35

Label at a glance#

ProductRed hot
Active ingredientCAPSAICIN
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, tendonitis, simple backache, and arthritis. Combined with stretching and calisthenics, Red Hot assists in the warm-up process, especially in cool, damp weather.

Dosage and administration

This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 12.5%

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Counterirritant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, tendonitis, simple backache, and arthritis. Combined with stretching and calisthenics, Red Hot assists in the warm-up process, especially in cool, damp weather.

Warnings

WARNINGS SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Use only as directed. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. For external use only.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

This product is intended to and will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Avoid getting into eyes or on mucous membranes. Do not apply to irritated or broken skin. Store in a cool, dry place with lid closed tightly.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Paraffin, Petrolatum

Questions?

OTC - QUESTIONS SECTION

(800) 345-2231

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label8Label8

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1923327capsaicin 0.05 % Topical OintmentPSN3
2597534Red Hot 0.05 % Topical OintmentPSN3
2597534capsaicin 0.0005 MG/MG Topical Ointment [Red Hot]SBD3
1923327capsaicin 0.0005 MG/MG Topical OintmentSCD3
1923327capsaicin 0.05 % Topical OintmentSY3
2597534Red Hot 0.0005 MG/MG Topical OintmentSY3
2597534Red Hot 0.05 % Topical OintmentSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82345-855-01Red hot454 g in 1 BOTTLEOINTMENT4543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82345-855RED HOT (CAPSAICIN) OINTMENT [THE HYGENIC COMPANY, LLC]3Current NDC, Legacy NDC, 1 package rows20231025_d100092c-e10b-2063-e053-2995a90aedb2.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82345-85582345-855-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
Red hotCAPSAICINThe Hygenic Company, LLCd100092c-e10b-2063-e053-2995a90aedb22023-10-25WarningsExact identifier
ndc (package): 82345-855-01
ndc (product): 82345-855
ndc11 (package): 82345085501
spl id: 0884b4eb-7fd2-b2c7-e063-6294a90aa02e
spl set id: d100092c-e10b-2063-e053-2995a90aedb2

Reported adverse events (FAERS/openFDA)#

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