Leader Roll-on Cooling Pain Relief Gel
FDA Label NDC 70000-0617

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Leader Roll-on Cooling Pain Relief (NDC 70000-0617). 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

DIST. BY CAH DUBLIN, OH 43017

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.

Flammable

  • ⬥keep away from excessive heat or open flame

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, 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 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
  • ⬥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

LEADER™

NDC 70000-0617-1

Roll-On
Cooling
Pain Relief
Gel

Menthol, 4% | Topical Analgesic

Pain Relieving Gel

For Arthritis
Back Pain
Sore Muscles
& Joints

Hands-Free
Roll-On
Applicator

Paraben-Free

COMPARE TO
BIOFREEZE®
active ingredient*

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2.5 FL OZ (74 mL)

Principal Display Panel (74 mL Bottle Label)

Principal Display Panel (74 mL Bottle Label)

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