Rite Aid Cool Therapy Gel

Manufacturer
Rite Aid | Anicare Pharmaceuticals Pvt. Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:47:59

Label at a glance#

ProductRite Aid Cool Therapy Gel
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, sprains

Dosage and administration

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary Children under 2 years of age: Consult physician

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, sprains

Warnings

WARNINGS SECTION

For external use only

Flammable:

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

Sensitive skin

When using this product:

OTC - WHEN USING SECTION

Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniments; Do not apply to irritated skin or if excessive irritated develops; Do not bandage; Wash hands after use with cool water; Do not use with a heating pad or device

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary

Children under 2 years of age: Consult physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylated hydroxy tolune, camphor, carbopol 940, edetate disodium, DMDM hydantoin, FD&C blue No.1, FD&C Yellow No. 5, Isopropyl Alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, Water

Questions or Comments

OTC - QUESTIONS SECTION

1-866-326-1313 Monday- Friday 8:30am-4:30 pm CST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-4217-12025-07-29C16284748780-11030e365-3c57-111a-e063-dadaa90a10e2Rite Aid Cool Therapy Gel
11822-4217-12024-12-19C16284748780-11030e365-3c57-111a-e063-dadaa90a10e2Rite Aid Cool Therapy Gel
11822-4217-12024-01-30C16284748780-11030e365-3c57-111a-e063-dadaa90a10e2Rite Aid Cool Therapy Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4217-1Rite Aid Cool Therapy Gel88.72 mL in 1 BOTTLEGEL88.722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4217RITE AID COOL THERAPY GEL (MENTHOL) GEL [RITE AID]2Legacy NDC, 1 package rows20241222_dfed135a-b55e-93d6-e053-2a95a90a90d6.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-421711822-4217-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
29a6c075-f678-8b7d-e063-6394a90a3998dfed135a-b55e-93d6-e053-2a95a90a90d62024-12-19WarningsExact identifier
spl id: 29a6c075-f678-8b7d-e063-6394a90a3998
spl set id: dfed135a-b55e-93d6-e053-2a95a90a90d6

Reported adverse events (FAERS/openFDA)#

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