K19 SPRAY RELIEF

Manufacturer
K19 LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:52:44

Label at a glance#

ProductK19 RELIEF
Active ingredientMENTHOL
Label structure7 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and stains.

Warnings:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • If symptoms persist for more than 7 days, discontinue use and consult physician.

Keep Out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Additional Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Camphor, Glycerin, Glyceryl Laurate, SD-Alcohol 40B.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1606487menthol 1.25 % Topical SprayPSN3
1606487menthol 12.5 MG/ML Topical SpraySCD3
1606487menthol 1.25 % Topical SpraySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83574-413-00K19 RELIEF295 mL in 1 BOTTLE, SPRAYLIQUID2953

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83574-413K19 RELIEF (MENTHOL) LIQUID [K19 LLC]3Current NDC, 1 package rows20250116_e2e1ca96-1ae8-4c99-b8de-ce26754292f9.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83574-41383574-413-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
K19 RELIEFMENTHOLK19 LLCe2e1ca96-1ae8-4c99-b8de-ce26754292f92025-01-15WarningsExact identifier
ndc (package): 83574-413-00
ndc (product): 83574-413
ndc11 (package): 83574041300
spl id: 2bbc8ed1-176c-27a5-e063-6394a90a38ee
spl set id: e2e1ca96-1ae8-4c99-b8de-ce26754292f9

Reported adverse events (FAERS/openFDA)#

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