Arnica Gel
FDA Label NDC 57955-3203

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Arnica Gel (NDC 57955-3203). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts__________________________________________________________________________________________________________

Active ingredient:

Arnica montana 1X HPUS*-7%

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

Indications & Usage

Uses Temporarily relieves: •swelling form minor injuries •muscle pain and stiffness, •and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been evaluated by the FDA. Product has not been clinically tested.

Warnings

Warnings:

  • For external use only. Avoid contact with eyes and broken skin.
  • If pregnant or breast-feeding, ask a health professional before use.
  • Nursing mothers should not apply to breast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Stop use and ask a doctor if: •symptoms worsen or do not improve within 3 days •skin irritation, redness or rash occurs.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

Directions: Apply to affected areas 2 or 3 times daily, or more often as needed. For best results, apply at the onset of symptoms.

Other Safety Information

Other information:

  • Do not use if carton or tube seal is broken.
  • Store at 68-77°F (20-25°C).
  • Keep carton for complete drug facts and product information.

Inactive Ingredient

Inactive ingredients:  Alcohol denat, carbomer, purified water, sodium hydroxide.

Otc - Purpose

Drug Facts

____________________________________________________________________________________________________________________

Active ingredients                                   Purpose†

Arnica montana.......................................Swelling from minor injuries, muscle pain and stiffness, bruising due to minor injuries or overexertion.

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

* Please review the disclaimer below.