Avcoo Pain Relief Roll On Cream
FDA Label NDC 84992-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Adp Health Limited for the product Avcoo Pain Relief Roll On (NDC 84992-002). 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, indications & usage, warnings, otc - keep out of reach of children, pregnancy, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

* Please review the disclaimer below.