Inflam-x
FDA Label NDC 35781-0230

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gensco Laboratories, Llc for the product Inflam-x (NDC 35781-0230). 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 warnings, otc - keep out of reach of children, otc - active ingredient, inactive ingredient, package label.principal display panel, indications & usage, warnings and precautions, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

FOR EXTERNAL USE ONLY             AVOID CONTACT WITH EYES

WARNINGS

For external use only. Do not ingest INFLAM-X PRO and avoid contact with the eyes and mucous membranes, wounds, and damaged skin. If condition worsens, or if symptoms persist for more than seven days or clear up and occur again within a few days, you should consult a doctor. If a rash develops, you should discontinue use until rash clears. After the disappearance of rash, you can try INFLAM-X PRO again on a test area and monitor the site for additional results. If no rash or redness results, then you can resume use. However, if the rash persists or redevelops, use should be discontinued.

Keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Otc - Active Ingredient

ACTIVE INGREDIENTS

Aconitum Napellus 3X, Arnica Montana 3X, Belladonna 4X, Bellis Perennis 1X, Calendula Officinalis 1X, Chamomilla 1X, Echinacea Angustifolia 1X, Echinacea Purpurea 1X, Hamamelis Virginiana 1X, Hypericum Perforatum 1X, Millefolium 1X, Symphytum Officinale 3X, Zingiber Officinale 1X.

DRUG FACTSPURPOSE
Aconitum Napellus 3X-HPUSNeuralgia
Arnica Montana 3X-HPUSHealing of Injured Tissue
Belladonna 4X-HPUSInflammation
Bellis Perennis TINC-HPUSBruising and Edema
Calendula Officinallis TINC-HPUSAnalgesia
Chamomilla TINC-HPUSTissue Healing
Echinacea Angustifolia TINC-HPUSInflammation
Echinacea Purpurea TINC-HPUSInflammation
Hamamellis Virginiana TINC-HPUSHematomas
Hypericum Perforatum TINC-HPUSNeuropathic Pains
Millefolium TINC-HPUSWound healing
Symphytum Officinale 4X-HPUSNeuropathy and Periostitus
Zingiber OfficinaleInflammation

Inactive Ingredient

INACTIVE INGREDIENTS

Purified water, Isopropyl Myristate, lecithin, Urea, Docusate Sodium, Sodium Hydroxide

Inactive Ingredients

Purified water, Isopropyl Myristate, Lecithin, Urea, Docusate Sodium

Package Label.Principal Display Panel

NDC 35781-0230-0     WWW.GENSCOLABS.COM

US PATENT #5,654,337


NDC 35781-0230-0

WWW.GENSCOLABS.COM


Inflam-x Box (Inflamxbox)

Inflam-x Box (Inflamxbox)

Label (Inflamxlabel)

Label (Inflamxlabel)

Drug Facts (Inflamxfactspanel)

Drug Facts (Inflamxfactspanel)

Indications & Usage

INFLAM-X PRO is a homeopathic topical analgesic gel that contains the ingredients listed below. Homeopathic ingredients have been used since the inception of this science and remain as an effective method of treating select conditions.It is an amber colored odorless gel for use externally to control inflammation and reduce pain.

Warnings And Precautions

For external use only. Do not ingest INFLAM-X PRO and avoid contact with the eyes and mucous membranes, wounds, and damaged skin. If condition worsens, or if symptoms persist for more than seven days or clear up and occur again within a few days, you should consult a doctor. If a rash develops, you should discontinue use until rash clears. After the disappearance of rash, you can try INFLAM-X PRO again on a test area and monitor the site for additional results. If no rash or redness results, then you can resume use. However, if the rash persists or redevelops, use should be discontinued.

Keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.

Otc - Purpose

INFLAM-X PRO is indicated for the temporary relief of inflammation and pain from injuries such as sprains, strains, repetitive use injuries, traumatic edema, general swelling of joints and soft tissue of the hand, wrist, elbow, shoulder, neck, back, knee, ankle, foot and toe. INFLAM-X PRO is also indicated for the reduction of bruising.

Dosage & Administration

Apply a thin layer (1 drop covers an area of skin 2 inches by 2 inches) to the affected area of the skin 3-4 times daily and rub in gently. Applications of less than 3-4 times a day will not produce optimum results. Excess drops may be wiped from the area. Safe to use on children over age of 2 years.

Information For Patients

Other Information

Store at room temperature

Manufactured for

Gensco Laboratories, LLC

Miramar, FL 33027

866.608.6284

US Patent # 5,654,337

www.genscolabs.com

Otc - Questions

Questions? Toll Free 1-866-608-6284   Mon-Fri 9AM to 5PM (EST)

* Please review the disclaimer below.