Procure Gel
FDA Label NDC 55681-015

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Twin Med, Llc for the product Procure Gel (NDC 55681-015). 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:, 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 5%

Purpose

Pain Relieving

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: ■Simple backache

Arthritis ■Strains ■Bruises ■Sprains

Warnings

For external use only

Flammable:

Keep away from excessive heat or open flame.

When Using This Product:

■Use only as directed

■Avoid contact with the eyes or on mucous membranes

■Do not apply to wounds or damaged skin

■Do not apply to irritated skin or if excessive irritation develops ■Do not bandage tightly or use with heating pad or device

Stop Use And Ask A Doctor If:

■You experience pain, swelling or blistering of the skin

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

■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age

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 right away.

Directions

■Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■Children under 2 years

of age: consult a physician ■Wash hands after use with cool water

Inactive Ingredients

: Aloevera Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Calendula Officinalis Extract, Carbopol, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerine, Green Tea Extract, Isopropyl Alcohol, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

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