Otc - Active Ingredient
Active Ingredients Purpose
Arnica Montana 1X HPUS (4%) Pain, Bruises, Injuries, Muscle Aches
Germa Arnica Relief
FDA Label NDC 59561-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Caribe Natural Llc for the product Germa Arnica Relief (NDC 59561-100). 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 - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, 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 - Purpose
Pain, Bruises, Inuries, Muscle Aches
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Germa Arnica Relief Gel
Homeopathic Medicine
Bruising & Swelling / Moreton e Hinchazon
Aches & Pains / Dolores y Molestia Muscular
Joints Pain / Dolores de Articulacion
Back Ache / Dolores de Espalda
Stiffness / Rigidez
Natural Pain Relief
Dosage & Administration
Directions:
For External Use Only. Apply generously to affected area, 2 to 3 times daily or as needed. Rub gently until complete absorption. Safe for children over 2 years old (under 2 years ask a Doctor).
Warnings
Warnings:
For External Use Only. Ask a Doctor before use if pregnant, or breast-feeding. When using this product: Do not get into eyes and do not apply on open skin. Stop use and ask a Doctor if: Condition worsens, symptoms last more than 7 days, or you are allergic to any of the ingredients.
Inactive Ingredient
Inactive Ingredients: aloe vera, caprylyl glycol, hexylene glycol, hydroxyethylcellulose, phenoxyethanol, potassium sorbate, purified water.
Package Label.Principal Display Panel
Image Description (Label)
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