Topcare Pain Relieving Roll-on Gel
FDA Label NDC 36800-290

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Pain Relieving Roll-on (NDC 36800-290). 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 other, active ingredient, purpose, uses, warnings, otc - ask doctor, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Flammable

  • keep away from excessive heat or open flame

    • DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

Active Ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have sensitive skin

When Using This Product

  • Avoid contact with eyes
  • 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 tightly
  • Wash hands after use with cool water
  • Do not use with heating pads or heating devices

Otc - Stop Use

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Massage not necessary.
  • Children under 2 years of age: Consult a doctor.

Other Information

Store in a cool dry place with lid closed tightly

Inactive Ingredients

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Questions Or Comments?

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Principal Display Panel - 74 Ml Bottle Label

TopCare
health®

COMPARE TO BIOFREEZE® ROLL-ON ACTIVE INGREDIENT*

Cold Therapy

Pain
Relieving
Rool-On Gel

with Menthol 4%

  • For Arthritis, Back Pain,
    Sore Muscles & Joints
  • No-Mess Applicator
  • Vanishing Scent
  • Paraben-Free

    • • OUR PHARMACISTS
    RECOMMEND •

    2.5 FL OZ (74 mL)

    Principal Display Panel (74 mL Bottle Label)

    Principal Display Panel (74 mL Bottle Label)

* Please review the disclaimer below.