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  5. Label Information: Arneu

FDA Label for Arneu

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - ASK DOCTOR
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arneu Product Label

The following document was submitted to the FDA by the labeler of this product Cc Medical Devices Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients

Camphor 3.100%

Menthol 3.000%


Otc - Purpose



Purpose

Topical Analgesic

Topical Analgesic


Indications & Usage



Uses

For the temporary relief of minor aches and pains of muscles and joints.

Penetrating pain relief.


Warnings



Warnings

For external use only.


Otc - Do Not Use



Do not bandage tightly.

Do not apply heat to the area of application.

Do not apply to open wounds or damaged skin.


Otc - When Using



Avoid contact with eyes or mucous membranes.


Otc - Ask Doctor



Ask a doctor before use, if you have ever experienced a reaction due to ingredients listed.


Otc - Stop Use



Stop use and consult a licensed health professional if conditions worsens or if symptoms persists for more than 7 days, or clears up and occurs again.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding, ask the health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

If ingestion occurs, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

Adults and children 12 years of age or older

Apply to surface, leaving a thin visible film; by applying a thicker film, the intensity is increased.

Apply to the area of pain, extending outside of the area slightly.

Apply 2 times a day minimum (do not exceed application of 4 times daily).

Allow to dry completely before applying loose clothing over the area.

Directions

(Children 12 years of age or younger)

Ask your doctor or a licensed health professional.


Storage And Handling



Other Information

Store at 15-30 C (50-85 F). Keep sealed tightly.

No triethanolamine used in manufacturing.

Have all medical diagnosis confirmed by a healthcare professional before treating.

Do not use if cap seal has been tampered with.


Inactive Ingredient



Inactive Ingredients

Water, propylene glycol, glycerin, witch hazel, carbomer, sodium hydroxymethylglycinate, fragrance, arnica montana flower extract, potassium asparate, sodium chlorite, willow bark extract, green tea leaf extract, sodium hydroxide, spirulina maxima extract, aloe vera leaf juice, ginger root extract, bromelain, boswellia serrata gum, sodium sesquicarbonate, sodium bicarbonate, capsaicin (capsicum frutescens fruit extract).


Package Label.Principal Display Panel



ArNeu

penetrating pain relief

God Formula

Topical Analgesic Counterirritant

For the Temporary Relief of Minor Aches and Pains of Muscles and Joints

NET WT. 3.0 OZ. (85 g.)

www.arneu.com

NDC 42046-002-03

US Pat.7,704,522 and Pat. Pending

Made in USA



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