H-BI HEMORRHOIDS FORMULA- calendula officinallis, hamamelis virginiana oil

H-BI Hemorrhoids Formula by

Drug Labeling and Warnings

H-BI Hemorrhoids 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

Hamamelis virginiana - 6C HPUS 

Purpose

Calendula officinalis - 12C HPUS (healing agent),

Hamamelis virginiana - 6C HPUS (anus raw, bleeding).

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,

Matricaria recutita flower, Pelargonium graveolens whole plant)

Indications:

For the temporary relief of hemorrhoid 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.

Do not use if pregnant or breastfeeding.

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-BI Hemorrhoids
Formula

Homeopathic

For External Use Only

005

11ml (0.37 fl. oz)
amoils.com

INGREDIENTS AND APPEARANCE

H-BI HEMORRHOIDS FORMULA  
calendula officinallis, hamamelis virginiana oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61077-005
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
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	6 [hp_C]  in 11 mL

Inactive Ingredients
Ingredient Name	Strength
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
CHAMOMILE (UNII: FGL3685T2X)
PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61077-005-11	11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013
2	NDC: 61077-005-33	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(61077-005)