H-BI Hemorrhoids Formula: Homeopathic Product Information

H-BI HEMORRHOIDS FORMULA — calendula officinalis flowering top and hamamelis virginiana root bark/stem bark oil
Healing Natural Oils LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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.

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

Healing Natural Oils

H-BI Hemorrhoids
Formula

Homeopathic

For External Use Only

005

11ml (0.37 fl. oz)
amoils.com

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_C] in 11 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_C] in 11 mL

Inactive Ingredients Ingredient Name Strength EUROPEAN HAZELNUT OIL HELICHRYSUM ITALICUM FLOWER CHAMOMILE PELARGONIUM GRAVEOLENS WHOLE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61077-005-11 11 mL in 1 BOTTLE, DROPPER None 2 NDC:61077-005-33 33 mL in 1 BOTTLE, DROPPER None

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	Operations
King Bio Inc		617901350	manufacture (61077-005)

Revised: 12/2017 Healing Natural Oils LLC