Leader™

Leader™
SPL v3
SPL
SPL Set ID fd06d17f-4dff-42a9-a84f-904809ceb981
Route
TOPICAL
Published
Effective Date 2024-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (40 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-03
Description

Drug Facts

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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.

Section 50569-3

Ask a doctor before use if you have sensitive skin

Section 53414-9

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

Warnings

For external use only

Flammable
  • keep away from fire or flame
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.
Active Ingredient

Menthol 4%

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?

1-866-567-8600

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
Principal Display Panel 89 Ml Tube Label

LEADER™

NDC 70000-0618-1

Cooling

Pain Relief

Gel

Menthol, 4% | Topical Analgesic

Pain Relieving Gel

For Backache

Muscle Pain

Joint Pain

Soothing

Menthol

COMPARE TO

BIOFREEZE®

active ingredient*

100% Money

Back Guarantee

3 FL OZ (89 mL)

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have sensitive skin

Section 53414-9 (53414-9)

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

Purpose

Topical analgesic

Warnings

For external use only

Flammable
  • keep away from fire or flame
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.
Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)

Store in a cool dry place with lid closed tightly.

Inactive Ingredients (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? (Questions or comments?)

1-866-567-8600

When Using This Product (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
Principal Display Panel 89 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 89 mL Tube Label)

LEADER™

NDC 70000-0618-1

Cooling

Pain Relief

Gel

Menthol, 4% | Topical Analgesic

Pain Relieving Gel

For Backache

Muscle Pain

Joint Pain

Soothing

Menthol

COMPARE TO

BIOFREEZE®

active ingredient*

100% Money

Back Guarantee

3 FL OZ (89 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:51.820499 · Updated: 2026-03-14T23:13:29.977510