Josephs Lion
FDA Label NDC 53196-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chan Yat Hing Medicine Factory for the product Josephs Lion (NDC 53196-001). 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 - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients
Camphor 3.5%
Menthol 5%

Otc - Purpose

Purpose
External analgesic

Warnings

Warnings
For external use only

Otc - Do Not Use


Do not use

  • on wounds
  • on irritated or damaged skin
  • otherwise than as directed

Otc - When Using

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation of the skin develops

    • when using for pain of arthritis:

    • pain persists for more than 10 days
    • redness is present
    • in conditions affecting children under 12 years of age

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning.
If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • adults and children 3 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 3 years of age: do not use, consult a physician.
  • refer to the above warnings; use otherwise than as directed may be dangerous.

Storage And Handling

Other information
keep container tightly closed
store at 15E to 30 C (59 to 86 F)

Inactive Ingredient

Inactive ingredients
Anise oil, cajuput oil, lavender oil, methyl salicylate,and mineral oil.

Otc - Questions

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

Indications & Usage

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
simple backache, arthritis, strains, bruises, sprains

* Please review the disclaimer below.