Maxrelief Arnica
FDA Label NDC 76509-700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natures Investment Holdings Pty Ltd Dba Maxrelief Usa for the product Maxrelief Arnica (NDC 76509-700). 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 inactive ingredient, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Inactive Ingredient

Inactive Ingredients: 100% Natural Arnica Montana Flower

Tincture, Rosemary Oil, Eucalyptus Oil. Also contains Emu Oil.

Ethanol and Water.

Otc - Active Ingredient

Active Ingredient   Camphor .3 % Minimum Content

Otc - Purpose

Purpose   External Analgesic

Indications & Usage

Use - For the temporary relief of minor aches and pains associated with sore

muscles, joint discomfort, strains, sprains and arthritis.

Warnings

Warning:  External use only.

Otc - When Using

When using this product: Avoid contact with eyes - Do not use on wounds, damaged

or irritated skin - Do not bandage, or use with heating pads or heating devices,

other ointments, creams, sprays or liniments.

Otc - Stop Use

Stop use and consult a doctor if: condition worsens - symptoms persist for

more than 7 days - symptoms clear up and reoccur

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:  If swallowed, get medical help or

contact a Poison Control Center immediately

Dosage & Administration

Directions: Adults and children 2 years of age or older: Most effective

when liberally applied to the affected, and importantly, the surrounding, areas.

Lightly rub in and reapply after 30 seconds. For optimum results, repeat 4 times

daily for 3 to 5 days. When the pain has subsided, apply once each

morning and evening for continued temporary relief.

Package Label.Principal Display Panel

Image Description (Arnica 2016)

Image Description (Arnica 2016)

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