Formula 8
FDA Label NDC 57520-0201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Formula 8 (NDC 57520-0201). 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, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Dosage & Administration

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

ACTIVE INGREDIENTS: Arnica Montana 6C, Bellis Perennis 6C, Hypericum Perforatum 12C, Phosphorus 30C, Rhus Toxicodendron.

Otc - Purpose

INDICATIONS: For the temporary relief of pain and inflammation associated with injuries, muscle spasms and pulls, bruises, and trauma.

Warnings

WARNINGS: Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for your protection." Do not use if seal is broken or missing.

Dosage & Administration

DIRECTIONS: 10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.