Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Camphor 4% | Topical Analgesic |
| Menthol 10.0% | Topical Analgesic |
| Methyl Salicylate 30% | Topical Analgesic |
Leader Ultra Strength Muscle Rub Cream
FDA Label NDC 70000-0208
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 Ultra Strength Muscle Rub (NDC 70000-0208). 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 otc - purpose, uses, warnings, do not use, otc - ask doctor, when using this product, stop use and consult a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
for the temporary relief of minor aches and muscles and joints associated with:
♦ arthritis♦ simple backache♦ strains♦ sprains
Warnings
For external use only
Do Not Use
♦ with a heating pad♦ on wounds, damaged, broken or irritated skin♦ on a child under 12 years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you have redness over the affected area
When Using This Product
♦ use only as directed♦ do not swallow♦ do not bandage tightly♦ avoid contact with the eyes and mucous membranes
Stop Use And Consult A Doctor If
♦ skin redness or irritation develops♦ condition worsens or pain lasts for more than 7 days♦ symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
♦ Adults and children 12 years of age and older: apply to affected area not more than 3 or 4 times daily♦ children under 12 years of age: ask a doctor
Other Information
Store at room temperature 15° - 30° C (59° - 86° F)
Inactive Ingredients
Carbomer, Disodium EDTA, Glyceryl Stearate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Trolamine, Water.
Questions Or Comments?
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DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
Principal Display Panel - 113 G Tube Carton
NDC 70000-0208-1
ULTRA STRENGTH
Muscle Rub
Topical Analgesic Pain Relief Cream
Deep Penetrating Relief of Muscle and Arthritis Pain
Non-Greasy Cream
COMPARE TO
BENGAY®
ULTRA STRENGTH
active ingredients*
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NET WT 4 OZ (113 g)
Principal Display Panel (113 g Tube Carton)
* Please review the disclaimer below.
