INFLAM-X- aconitum napellus, arnica montana, belladonna, bellis perennis, calendula officinallis, chamomilla, echinacea angustifolia, echinacea purpurea, hamamellis virginiana, hypericum perforatum, millefolium, symphytum officinale, zingiber officinale gel

INFLAM-X by

Drug Labeling and Warnings

INFLAM-X by is a Homeopathic medication manufactured, distributed, or labeled by Gensco Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

FOR EXTERNAL USE ONLY             AVOID CONTACT WITH EYES

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

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.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

NDC: 35781-0230-0     WWW.GENSCOLABS.COM

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.

PRINCIPAL DISPLAY PANEL

US PATENT #5,654,337

NDC: 35781-0230-0

WWW.GENSCOLABS.COM

ACTIVE INGREDIENT

DRUG FACTS	PURPOSE
Aconitum Napellus 3X-HPUS	Neuralgia
Arnica Montana 3X-HPUS	Healing of Injured Tissue
Belladonna 4X-HPUS	Inflammation
Bellis Perennis TINC-HPUS	Bruising and Edema
Calendula Officinallis TINC-HPUS	Analgesia
Chamomilla TINC-HPUS	Tissue Healing
Echinacea Angustifolia TINC-HPUS	Inflammation
Echinacea Purpurea TINC-HPUS	Inflammation
Hamamellis Virginiana TINC-HPUS	Hematomas
Hypericum Perforatum TINC-HPUS	Neuropathic Pains
Millefolium TINC-HPUS	Wound healing
Symphytum Officinale 4X-HPUS	Neuropathy and Periostitus
Zingiber Officinale	Inflammation

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.

WARNINGS

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.

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

INACTIVE INGREDIENT

Inactive Ingredients

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

QUESTIONS

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

INFORMATION FOR PATIENTS

Manufactured for

Gensco Laboratories, LLC

Miramar, FL 33027

866.608.6284

US Patent # 5,654,337

www.genscolabs.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INFLAM-X 
aconitum napellus, arnica montana, belladonna, bellis perennis, calendula officinallis, chamomilla, echinacea angustifolia, echinacea purpurea, hamamellis virginiana, hypericum perforatum, millefolium, symphytum officinale, zingiber officinale gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35781-0230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]  in 6 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 6 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	4 [hp_X]  in 6 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	1 [hp_X]  in 6 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 6 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	1 [hp_X]  in 6 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_X]  in 6 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	1 [hp_X]  in 6 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1 [hp_X]  in 6 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	1 [hp_X]  in 6 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	1 [hp_X]  in 6 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	4 [hp_X]  in 6 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	1 [hp_X]  in 6 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
UREA (UNII: 8W8T17847W)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35781-0230-0	1 in 1 BOX
1		6 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/17/2010

Labeler - Gensco Laboratories, LLC (831042325)

Registrant - Gensco Laboratories, LLC (831042325)

Establishment
Name	Address	ID/FEI	Business Operations
Gensco Laboratories, LLC		831042325	manufacture(35781-0230)