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  5. Label Information: Avcoo Pain Relief Roll-on

FDA Label for Avcoo Pain Relief Roll-on

View Indications, Usage & Precautions

Table of Contents

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

Avcoo Pain Relief Roll-on Product Label

The following document was submitted to the FDA by the labeler of this product Adp Health Limited. 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 ingredient

Menthol 4%


Otc - Purpose



Purpose

Topical Analgesic


Indications & Usage



Uses

Temporary relief from minor aches and pains of sore muscles and joints


Warnings



Warnings

  • Please read all directions and warnings as follows and use only as directed. For external use only.
  • Flammable:Keep away from excessive heat and open flame
  • Do not bandage tightly or use with heating pad or device
  • Avoid contact with eyes
  • Do not apply to wounds or damaged skin

Otc - Keep Out Of Reach Of Children



Keep out of reach of children or pets. If swallowed, get medical help or contact a Poison Control Center right away


Pregnancy



If pregnant or breast-feeding,ask a healthcare professional before use


Otc - Do Not Use



Do not use

  • if you are allergic to the listed ingredients
  • if the package arrives damagedor opened
  • at the same time as other topical analgesics
  • on mucous membrances, cuts, broken, swollen, or irritated skin

    • Do not use

    • if you are allergic to the listed ingredients
    • if the package arrives damagedor opened
    • at the same time as other topical analgesics
    • on mucous membrances, cuts, broken, swollen, or irritated skin

Otc - Stop Use



Stop Use and Ask a Doctor

if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.

if you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering


Dosage & Administration



Directions 

  • Rub a thin film over the affected area no more than 3-4 times daily
  • Wash hands after use with cold water
  • Children under 12 years of age: do not use, consult a doctor

Storage And Handling



Other Information

  • store in a dry place at room temperature between 20-25C (77-86F) and away from direct sunlight

Inactive Ingredient



Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extrac, Calendula Officinalis Flower Extract,  Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue NO.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, IsopropyI Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water


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