Leader ™ Roll-On Cooling Pain Relief Gel Topical Analgesic

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have sensitive skin

When using this product

OTC - WHEN USING SECTION

• 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 SECTION

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

SPL UNCLASSIFIED SECTION

• keep away from excessive heat or open flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

Store in a cool dry place with lid closed tightly.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

DIST. BY CAH DUBLIN, OH 43017

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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*

100% Money
Back Guarantee

2.5 FL OZ (74 mL)

DailyMed RxNorm Mappings#

DailyMed Package Descriptions#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

• Leader Roll-On Cooling Pain Relief Topical Analgesic
• MENTHOL, UNSPECIFIED FORM
• ALOE VERA LEAF
• Arnica Montana Flower
• FD&C BLUE NO. 1
• INDIAN FRANKINCENSE
• Calendula Officinalis Flower
• GREEN TEA LEAF
• CAMPHOR (SYNTHETIC)
• CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
• Glycerin
• Isopropyl Alcohol
• Isopropyl Myristate
• SILICON DIOXIDE
• Sodium Hydroxide
• .ALPHA.-TOCOPHEROL ACETATE, DL-
• Water
• FD&C YELLOW NO. 5

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.