H-Cold Sores Formula: Homeopathic Product Information

H-COLD SORES FORMULA- calendula officinalis flowering top and ranunculus bulbosus 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,

Ranunculus bulbosus- 12C HPUS

Purpose

Calendula officinalis -12C HPUS (for herpes, healing agent), Ranunculus bulbosus -12C HPUS (herpetic eruptions) The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States

Inactive Ingredients:

Essential Oil Blend (Cymbopogon martinii aerial parts, Lavandula officinalis flower bud, Litsea cubeba seed, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant)

Indications:

For the treatment of cold sore symptoms, such as fever blisters, soreness at blister site.

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 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 1042 N El Camino Real,

#B-426, Encinitas, CA 92024 USA

Principal Display Panel

Healing Natural Oils

H-Cold Sores
Formula

Homeopathic

For External Use Only

127

11ml (0.37 fl. oz) amoils.com

H-COLD SORES FORMULA calendula officinalis, ranunculus bulbosus oil

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61077-127 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 RANUNCULUS BULBOSUS (RANUNCULUS BULBOSUS) RANUNCULUS BULBOSUS 12 [hp_C] in 11 mL

Inactive Ingredients Ingredient Name Strength CYMBOPOGON MARTINI TOP LAVANDULA ANGUSTIFOLIA FLOWER LITSEA CUBEBA FRUIT MELALEUCA ALTERNIFOLIA LEAF PELARGONIUM GRAVEOLENS WHOLE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61077-127-11 11 mL in 1 BOTTLE, DROPPER None 2 NDC:61077-127-33 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 (61077-127)

Revised: 12/2019 Healing Natural Oils LLC