P3 oa - Prescription Drug Labeling

Active ingredient

A list of the active, medicinal ingredients in the drug product.

Active Ingredients Saccharomyces Cerevisiae Glycerin

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.

Directions Apply as needed. Children under 6 months: ask a doctor Apply the monodose gel on a patch gauze to clean dry skin. Place the patch on the affected area. Wear the patch for 4-8 hours.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.

Inactive ingredients Aqua, Benzoic acid, Carbomer, Dehydroacetic acid, Disodium EDTA, Ethylhexylglycerin, Panthenol, PEG-40 hydrogenated castor oil, Phenoxyethanol, Propylene glycol, Sodium hyaluronate, Sodium hydroxide, Xanthan gum

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.

Uses Apply the monodose gel on a patch gauze to clean dry skin. Place the patch on the affected area. Wear the patch for 4-8 hours.

Purpose

Information about the drug product’s indications for use.

Purpose Pre and post regenerative skin protectant topical For the temporary relief of moderate aches and pains of muscles and joints associated with Osteoarthritis

Spl product data elements

Usually a list of ingredients in a drug product.

P3 OA P3 OA SACCHAROMYCES CEREVISIAE SACCHAROMYCES CEREVISIAE PANTHENOL WATER ETHYLHEXYLGLYCERIN PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER CARBOMER 934 PEG-40 CASTOR OIL PHENOXYETHANOL PROPYLENE GLYCOL BENZOIC ACID GLYCERIN GLYCERIN MAGNESIUM DISODIUM EDTA XANTHAN GUM SODIUM HYDROXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.

Principal Display Panel Secondary Pack

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.

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

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.

Questions @ [email protected]

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.

Stop use and ask doctor if Condition Worsens Symptoms last more than 7 days

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.

Warnings For External Use Only For External Use Only Do not use other creams or cosmetics with the monodose. Do not get the area wet once the patch is in place. Avoid contact with eyes Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask doctor if Condition Worsens Symptoms last more than 7 days