Avcoo Pain Relief Gel
FDA Label NDC 84992-003

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 (NDC 84992-003). 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 4%

Otc - Purpose

Purpose

Topical Analgesic

Indications & Usage

Uses

Temporarily relieves 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
  • 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

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

Arctium Lappa Extract, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol,  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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