HEMORRHOID-X TREATMENT PACK kit

Hemorrhoid-X Treatment Pack by

Drug Labeling and Warnings

Hemorrhoid-X Treatment Pack by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratorios Homeopaticos SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Hemorrhoid-x Treatment Pack - Hemorrhoidex Tablets

Drug Facts

Active Ingredient (in each tablet)

Aesculus Hipp 6C HPUS*

Collinsonia 6C HPUS*

Hamamelis 6C HPUS*

Purpose

Aesculus Hipp 6C HPUS*.........Hemorrhoids, pain after stool, aching, swollen, burning in anus

Collinsonia 6C HPUS*.........Hemorrhoids, itching or burning in anus with swelling

Hamamelis 6C HPUS*.......Hemorrhoids, pulsation in rectum

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "C" is an homeopathic dilution. See www.nartexlabsusa.com formore information.

Uses

Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with hemorrhoids. Product claims and Uses are based on Homeopathic Materia Medica not clinical test. This product and its Uses have not been evaluated by the Food and Drug Administration. This product has not been clinically tested by Nartex Labs USA, Inc.

Warnings

ASK DOCTOR

Ask a doctor before use if you are

• under a doctor's care for any serious condition
• taking any other drug

STOP USE

Stop use and ask a doctor if

• Symptoms persist, worsen, or if new symptoms occur after 7 days
• rash develops

WHEN USING

When using this product

• do not exceed recommended daily dosage unless directed by a physcian.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Adults and childrenover 12 years: take 2 tablets every 6 hours
• Children under 12 years of age: consult a physician

Other Information

Store in a cool and dry place.

Inactive Ingredients

Gelatin, Lactose, Magnesium stearate, Potato stach, Sodium Benzoate, Talc

Questions or Comments?

Call 1-877-248-1970 between 9am and 5pm PT.

Informacion@nartexlabs.com

SPL UNCLASSIFIED SECTION

Product of Mexico / Producto de Mexico

Distributed by: Nartex Labs, USA, Inc.

11711 Memorial Drive #685

Houston, TX 77024

www.nartexlabsusa.com

Hemorrhoid-x Treatment Pack - Hemorrhoidex ointment

Drug Facts

Active Ingredients

Ratanhia 3X HPUS*

Hamamelis 1X HPUS*

Purpose

Ratanhia 3X HPUS*....Hemorrhoids, pain after stool, burning in anus

Hamamelis 1X HPUS*.......Hemorrhoids, pulsation in rectum

*The letters HPUS indicate that the components in this product are offically monographed in the Homeopathic Pharmacopoeia of the United States. X is an homeopathic dilution: see www.nartexlabsusa.com for more information.

Uses

Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with hemorrhoids. Product claims and Uses are based on Homeopathic Materia Medica not clinical test. This product and its Uses have not been evaluated by the Food and Drug Administration. This product has not been clinically tested by Nartex Labs USA, Inc. This product has not been shown to relieve symptoms such as itching, burning, and swelling associated with hemorrhoids.

Warnings

For external use only.

DO NOT USE

Do not use

• if you have an allergy or hypersensitivity to the components of the fourmal or have had a prior reaction to this product.

ASK DOCTOR

Ask a doctor before use if you are

under a doctor's care for any serious condition
taking any other drug

WHEN USING

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
• do not exceed the recommended daily dosage unless directed by physician
• do not put into the rectum by use of fingers or any mechanical device or applicator

STOP USE

Stop use and ask a doctor if

• bleeding occurs
• symptoms persist, worsen, or if new symtoms occur after 7 days
• rash develops

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, consult a health professional before use,

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Apply generously to affected area up to 2 times daily, especially at night, in the morning or after each bowel movement.
• reapply if needed
• Children under 12 years of age, consult a phsyician.

Other Information

• do not use if tube seal is broken or missing
• store in a cool and dry place
• there is no scientific evidence that the product works. Product claims are based only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Inactive Ingredients

Glycerin, Glyceryl monostearate, Lanolin, Purifed water, Talc, White petrolatum

Questions or Comments?

1-877-248-1970 between 9am and 5pm CST.

informacion@nartexlabs.com

Principal Display Panel

TREATMENT PACK

HOMEOPATHIC

HEMORRHOID-X

Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with

Hemorroids

COMBO pack

There is no scientific evidence that the product works. Product's claims are based only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Contains

1 tube Net. Wt. 1.0oz (28.35g) and 1 box 30 tablets.

INGREDIENTS AND APPEARANCE

HEMORRHOID-X TREATMENT PACK 
hemorrhoid-x treatment pack kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-291

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-291-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	04/11/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	30 BOX	30
Part 2		2   in 2

Part 1 of 2

HEMORRHOIDEX 
hemorrhoidex tablet

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COLLINSONIA CANADENSIS WHOLE (UNII: IOS9HV04K7) (COLLINSONIA CANADENSIS WHOLE - UNII:IOS9HV04K7)	COLLINSONIA CANADENSIS WHOLE	6 [hp_C]
AESCULUS HIPPOCASTANUM WHOLE (UNII: 2331W47PSX) (AESCULUS HIPPOCASTANUM WHOLE - UNII:2331W47PSX)	AESCULUS HIPPOCASTANUM WHOLE	6 [hp_C]
HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) (HAMAMELIS VIRGINIANA WHOLE - UNII:V663Q8TEFU)	HAMAMELIS VIRGINIANA WHOLE	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
STARCH, POTATO (UNII: 8I089SAH3T)
TALC (UNII: 7SEV7J4R1U)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (white)	Score	score with uneven pieces
Shape	ROUND ((tablet))	Size	10mm
Flavor		Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/11/2019

Part 2 of 2

HEMORRHOIDE-X 
hemorrhoide-x ointment

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KRAMERIA LAPPACEA WHOLE (UNII: 97AC37R8BM) (KRAMERIA LAPPACEA WHOLE - UNII:97AC37R8BM)	KRAMERIA LAPPACEA WHOLE	3 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV)	HAMAMELIS VIRGINIANA LEAF	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LANOLIN (UNII: 7EV65EAW6H)

Product Characteristics
Color	white	Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/11/2019

Labeler - Nartex Laboratorios Homeopaticos SA DE CV (589914576)

Registrant - Nartex Laboratorios Homeopaticos SA DE CV (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratorios Homeopaticos SA DE CV		589914576	manufacture(34666-291)