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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 10%

Methyl Salicylate: 20%


Otc - Purpose



Purpose

Topical Analgesic


Indications & Usage



Uses

Temporary relief from minor aches and pains of sore muscles and joints associatedly with:

simple backaches, arthritis, strains, bruises, and sprain


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 heat or microwave
  • Do not add to hot water or any container with heated water, as it may cause splattering and resultin burns
  • Do not bandage tightly
  • Avoid contact with eyes
  • For sensitive skins, use with caution
  • So not squeeze the bottle during application

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
  • with a heating pad
  • on mucous membrances, cuts, broken, swollen, or irritated skin

Otc - Stop Use



Stop Use and Ask a Doctor

  • if you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering
  • if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.

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

Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water


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