Walgreens Cold Pain Relief
FDA Label NDC 0363-0874

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens, Co for the product Walgreens Cold Pain Relief (NDC 0363-0874). 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:, ask a doctor before use if you have:, when using this product:, stop use and ask a doctor if:, if pregnant or breast-feeding:, 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

Cooling Pain Relief

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 irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place.

Stop Use And Ask A Doctor If:

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

If Pregnant Or Breast-Feeding:

Ask a health professional before use

Keep Out Of Reach Of Children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and Children 2 years of age and older: rub a thin film over affected areas not more than four times daily; massage not necessary.
• Children under 2 years of age: Consult physician

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions Or Comments:

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