Extra Strength Cold and Hot Menthol Patch

Manufacturer
Rite Aid Corporation | Foshan Aqua Gel Biotech
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:55

Label at a glance#

ProductExtra Strength Cold and Hot Menthol Patch
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure12 sections

Indications and uses

Temporarily relieves minor pain.

Dosage and administration

Directions Adults and children 12 years of age and over : ■ Carefully remove backing from patch ■ Apply sticky side of patch to affected area. ■ Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily.. ■ Discard patch after single use. ■Reseal pouch after opening. ■Children under 12 years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Uses

OTC - PURPOSE SECTION

Temporarily relieves minor pain.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

■ use only as directed

■ rear cases of serious burns have been reported with products of this type

■ Don't bandage tightly or use with a heating pad

■ Avoid contact with the eyes and mucous membranes

■Don't apply to wounds or damaged skin

■ Do not use at the same time as other topical analgesics

Stop use and consult a doctor

OTC - STOP USE SECTION

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and over :

■ Carefully remove backing from patch

■ Apply sticky side of patch to affected area.

■ Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily..

■ Discard patch after single use.

■Reseal pouch after opening.

■Children under 12 years of age: consult a physician.

Other Safety Information

Store at room temperature, not to exceed 86F (30C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerin, iodopropynyl butylcarbamate, Kaolin, mineral oil, petrolatum, Phenoxyethanol, polyacrylic acid, Polysorbate 80, Povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain.

Extra Strength Cold & Hot Menthol Patch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN4
420222menthol 0.05 MG/MG Medicated PatchSCD4
420222menthol 5 % Medicated PatchSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-6513-1Extra Strength Cold and Hot Menthol Patch1 g in 1 PATCHPATCH14
11822-6513-1Extra Strength Cold and Hot Menthol Patch5 in 1 CARTONPATCH54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-6513EXTRA STRENGTH COLD AND HOT MENTHOL PATCH (MENTHOL) PATCH [RITE AID CORPORATION]4Current NDC, Legacy NDC, 2 package rows20241220_bd46ac50-aaf8-b4e8-e053-2995a90aea61.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-651311822-6513-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
Extra Strength Cold and Hot Menthol PatchMENTHOLRite Aid Corporationbd46ac50-aaf8-b4e8-e053-2995a90aea612024-12-18WarningsExact identifier
ndc (package): 11822-6513-1
ndc (product): 11822-6513
ndc11 (package): 11822651301
spl id: 299166ab-186e-9111-e063-6394a90aee4a
spl set id: bd46ac50-aaf8-b4e8-e053-2995a90aea61

Reported adverse events (FAERS/openFDA)#

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