H-FISSURES FORMULA- calendula officinalis, chamomilla oil

H-Fissures Formula by

Drug Labeling and Warnings

H-Fissures Formula by is a Homeopathic medication manufactured, distributed, or labeled by Healing Natural Oils LLC, King Bio, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Calendula officinalis -12C HPUS   
Chamomilla - 6C HPUS

Purpose

Calendula officinalis - 12C HPUS (healing agent),
Chamomilla - 6C HPUS (soreness of anus, painful fissures).

The letters ‘HPUS’ indicate that the components in this product are officially
monographed in the Homoeopathic Pharmacopoeia of the United States

Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Helichrysum
italicum flower, Lavandula officinalis flower
bud, Matricaria recutita flower)

Indications:

For the temporary relief of anal fissure symptoms such as burning, soreness and minor bleeding.

Directions:

Adults and Children 4 yrs and over:  Wash hands before and after use.
Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day.
Do not oversaturate or exceed dosage.

Warnings:

For external use only.
Perform skin test prior to initial use.

If pregnant or breastfeeding consult a doctor before use.

Keep out of reach of children.

Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control
Center right away.

Discontinue use if irritation occurs.

Consult a doctor if symptoms worsen after 7 days.

DESCRIPTION

Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H-Fissures

Formula

Homeopathic

For External Use Only

036

11ml (0.37 fl. oz)
amoils.com

INGREDIENTS AND APPEARANCE

H-FISSURES FORMULA  
calendula officinalis, chamomilla oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61077-036
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	12 [hp_C]  in 11 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) ( MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C]  in 11 mL

Inactive Ingredients
Ingredient Name	Strength
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CHAMOMILE (UNII: FGL3685T2X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61077-036-11	11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013
2	NDC: 61077-036-33	33 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/06/2013

Labeler - Healing Natural Oils LLC (113679703)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio, Inc.		617901350	manufacture(61077-036)