Otc - Active Ingredient
Menthol 4.3%................External analgesic
Camphor 4.3%..............External analgesic
Golden Remedy Extra Strength
FDA Label NDC 87037-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Golden Care Botanicals Llc for the product Golden Remedy Extra Strength (NDC 87037-002). 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, otc - do not use, warnings, otc - stop use, inactive ingredient, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic for temporary relief of pain/itching due to sunburn, minor burns, insect bites, and everyday aches
Otc - Do Not Use
Don not use on open wounds, broken skin, or with a heating pad
Warnings
For external use only
Otc - Stop Use
Stop use and ask a medical doctor if condition worsens, or symptoms persist
Inactive Ingredient
Inactive ingredients: Aaloe vera juice, Witch hazel, Avocado oil, Menthol crystals, Camphor, Ginger essential oil, Frankincense essential oil, Helichrysum essential oil, Optiphen, and Vitamin E
Dosage & Administration
Directions: Adults and children 12+ years and older. Apply to affected area not more than 3-4 times per day
Indications & Usage
Route of administration: Topical
Otc - Keep Out Of Reach Of Children
If swallowed, seek immediate medical attention or contact Poison Control
* Please review the disclaimer below.
