Herbalgy
FDA Label NDC 66897-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wicsun Trading for the product Herbalgy (NDC 66897-003). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, 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
Methyl Salicylate 31.5%
Menthol 16%
Camphor 10%

Otc - Purpose

Purpose
External Analgesic
External Analgesic
External Analgesic

Indications & Usage

Uses: For the temporary relief of minor aches and pains of muscles and joints associated withsimple backache, strains, bruises and sprains.

Warnings

Warnings: FOR EXTERNAL USE ONLY

Otc - Do Not Use

Do not use
  • Apply on wounds, irritated or damaged skin.
  • Otherwise than as directed

Otc - When Using

When using this product
  • Avoid contact with the eyes, mouth 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 or clear up and occur again within a few days.
  • Excessive irritation of the skin develops.
  • When using this product for arthritis: Pain persists for more than 10 days, redness is present or in conditions affecting children under 12 years of age

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, see the advise of a health professional before using this product.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning. If swallowed, contact a Doctor or Poison Control Center immediately

Dosage & Administration

Directions
Adults and children2 years of age and older: Apply to affected area not more than 3-4 times daily.
Children under 2 years of age: Do not use, consult a doctor

Inactive Ingredient

Inactive Ingredients: Eucalyptus oil, Olibanum, Myrhha resins, Corydalis rhizome and Drynaria fortunei extracts

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Package Label

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