FISSURE CONTROL- calendula officinalis flowering top and hamamelis virginiana root bark/stem bark solution/ drops

Fissure Control by

Drug Labeling and Warnings

Fissure Control by is a Homeopathic medication manufactured, distributed, or labeled by Forces of Nature. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredients

* USDA Certified Organic

Hamamelis Virginiana* 6X - Relief of Hemorrhoids that are Sore or Burning

Calendula Officinalis* 6X - Promotes Healthy Skin

Also Contains

Sesame Oil*, Helichrysum Oil*, German Chamomile Oil*, Lavandin Oil*

Indications

For the relief of inflammation, pain, itching and redness associated with hemorrhoids/fissures. Symptoms of fissures include an anal tear, pain during or after bowel movements, blood in the stool.

Directions

Shake well before use. Dab 2-3 drops of oil to treatment area 2-4 times per day; apply daily until problem is gone. For children under 2 years of age, consult a doctor before use.

Warnings

Do not put this product into the rectum by using fingers or any mechanical device or applicator. Some individuals may be sensitive to essential oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin. For external use only. If accidental ingestion of more than several drops, and adverse reaction occurs, get medical help or contact a Poison Control Center. Do not apply to the eyes. If you are pregnant or breast-feeding, ask a health professional before use. Not for use on children under the age of 2 without physician direction.

Keep all medicines out of the reach of children.

Stop use and consult a doctor if condition worsens, or consult a doctor if symptoms show no improvement after 7 days.

Tips For Use

Fissure Control's soothing ingredients offer immediate relief from pain and discomfort caused by fissures. It also quickly repairs the damaged tissue and encourages your body to heal itself faster than it would be able to without the medicine.

The pain relief can often be felt immediately. Torn skin is typically healed within one week, but more severe cases may require longer treatment time. The healing time can be made longer or shorter, depending on a few factors including:

• Constipation and straining during bowel movements.
• The length of time your fissure has existed - The longer the symptom has been present the longer the treatment will take.
• Your application schedule - Fissure Control should be applied at least 2-3 times every day while the symptom exists.

SPL UNCLASSIFIED SECTION

Manufactured by:
Forces of Nature, Inc.
21787 8th St East #3A
Sonoma, CA 95476 USA

PRINCIPAL DISPLAY PANEL - 5 ml Bottle Label

FORCES OF NATURE®

Fissure
CONTROL

FDA REGISTERED HOMEOPATHIC
FISSURE MEDICINE

USDA
ORGANIC

.17 OZ/5 ml

INGREDIENTS AND APPEARANCE

FISSURE CONTROL 
calendula officinalis flowering top and hamamelis virginiana root bark/stem bark solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51393-6334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	6 [hp_X]  in 1000 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	6 [hp_X]  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
Lavandin Oil (UNII: 9RES347CKG)
Sesame Oil (UNII: QX10HYY4QV)
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51393-6334-1	11 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/06/2011
2	NDC: 51393-6334-2	33 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/06/2011
3	NDC: 51393-6334-5	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		04/06/2011

Labeler - Forces of Nature (050169130)