H-Fissures Formula: Homeopathic Product Information

H-FISSURES FORMULA — calendula officinalis flowering top and matricaria recutita 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 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 officiallymonographed 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.

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

Healing Natural Oils

H-Fissures

Formula

Homeopathic

For External Use Only

036

11ml (0.37 fl. oz) amoils.com

H-FISSURES FORMULA calendula officinalis, chamomilla oil

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

Inactive Ingredients Ingredient Name Strength EUROPEAN HAZELNUT OIL HELICHRYSUM ITALICUM FLOWER LAVANDULA ANGUSTIFOLIA FLOWER CHAMOMILE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61077-036-11 11 mL in 1 BOTTLE, DROPPER None 2 NDC:61077-036-33 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 (61077-036)

Revised: 12/2017 Healing Natural Oils LLC