drug facts

drug facts
SPL v4
SPL
SPL Set ID 6989a6d3-d6d0-4f6a-96bc-827458d6af49
Route
topical
Published
Effective Date 2015-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
krameria lappacea root (3 [hp_X]) hamamelis virginiana root bark/stem bark (1 [hp_X])
Inactive Ingredients
glycerin lanolin glyceryl monostearate talc water white petrolatum

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2015-04-17

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 officially monographed in the Homeopathic Pharmacopoeia of the United States.  TINC is a homeopathic dilution: see www.nartexlabusa.com for details.

Description

Ratanhia ........................3X HPUS Hamamelis ....................1X HPUS


Medication Information

Warnings

For external use only

Uses
Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with hemorrhoids. Product Uses are based on Homeopathic Materia Medica. 

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.




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 officially monographed in the Homeopathic Pharmacopoeia of the United States.  TINC is a homeopathic dilution: see www.nartexlabusa.com for details.
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 physician

Other Information
  • do not use if plastic seal around cap is broken or missing
  • store in a cool and dry place

Inactive Ingredients

Glycerin, Glyceryl Monostearate, Lanolin, Purified Water, Talc USP, White petrolatum

Description

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial dr #685

Houston TX 77024

www.nartexlabusa.com

Principal Display Panel

HEMORRHOIDEX

ointment

Homeopathic Hemorrhoid Ointment







Net Wt. 1.0 oz (28.35g)

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • bleeding occurs

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

Section 50567-7

When using this product

  • avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water
  • do not exceed the recommended daily dosage unless directed by physician

Section 50569-3

Ask a doctor before use if you are

  •    under a doctor's care for any serious condition
  •    taking any other drug
Section 50570-1

Do not use

  • if you have an allergy or hypersensitivity to components of the formula or if you have had a prior reaction to this product
Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Active Ingredients

Ratanhia........................3X HPUS

Hamamelis....................1X HPUS

Questions Or Comments?

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

[email protected]


Structured Label Content

Warnings

For external use only

Uses
Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with hemorrhoids. Product Uses are based on Homeopathic Materia Medica. 

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.




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 officially monographed in the Homeopathic Pharmacopoeia of the United States.  TINC is a homeopathic dilution: see www.nartexlabusa.com for details.
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 physician

Other Information
  • do not use if plastic seal around cap is broken or missing
  • store in a cool and dry place

Inactive Ingredients

Glycerin, Glyceryl Monostearate, Lanolin, Purified Water, Talc USP, White petrolatum

Description (34089-3)

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial dr #685

Houston TX 77024

www.nartexlabusa.com

Principal Display Panel

HEMORRHOIDEX

ointment

Homeopathic Hemorrhoid Ointment







Net Wt. 1.0 oz (28.35g)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • bleeding occurs

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

Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water
  • do not exceed the recommended daily dosage unless directed by physician

Section 50569-3 (50569-3)

Ask a doctor before use if you are

  •    under a doctor's care for any serious condition
  •    taking any other drug
Section 50570-1 (50570-1)

Do not use

  • if you have an allergy or hypersensitivity to components of the formula or if you have had a prior reaction to this product
Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Active Ingredients

Ratanhia........................3X HPUS

Hamamelis....................1X HPUS

Questions Or Comments? (Questions or comments?)

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

[email protected]


Advanced Ingredient Data


Raw Label Data

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