Arnica Power Liquid
FDA Label NDC 61096-1032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eight And Company L.l.c for the product Arnica Power (NDC 61096-1032). 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, warnings, otc - keep out of reach of children, dosage & administration, otc - purpose, other safety information, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Arnica montana 3X, 4X, 6X

Warnings

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions: Adults and children over 12: 2 sprays under the tongue 3 times per day. For additional symptom relief spray directly  on the affected area and massage gently into the skin. Repeat 3 times a day or as needed. Ages 2-12: 1 spray under the tongue 3 times per day. For additional symptom relief, spray directly on the affected area 3 times per day. Under age 2: consult a doctor prior to use.

Otc - Purpose

Temporarily relieves symptoms associated with overexertion or trauma, such as:

  • muscle aches
  • stiffness
  • swelling from injuries
  • bruising

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v, purified water.

Indications & Usage

Temporarily relieves symptoms associated with overexertion or trauma, such as:

  • muscle aches
  • stiffness
  • swelling from injuries
  • bruising

    • ° natural

    ° gluten free

    ° no artificial flavors or colors

    ° vegan

    ° no known negative side effects

    ° no known negative drug interactions

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