Rite Aid Cool Therapy Gel
FDA Label NDC 11822-4217

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Rite Aid Cool Therapy Gel (NDC 11822-4217). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, flammable:, ask a doctor before use if you have:, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 4%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only

Flammable:

Keep away from excessive heat or open flame.

Ask A Doctor Before Use If You Have:

Sensitive skin

When Using This Product:

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:

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

If Pregnant Or Breast-Feeding:

Ask a health professional before use

Keep Out Of Reach Of Children:

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

Directions

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

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

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

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