425bc0e8-c884-40cc-90e9-490e50f733c3

SPL v8

SPL

SPL Set ID 425bc0e8-c884-40cc-90e9-490e50f733c3

Route

topical

Published

Effective Date 2013-11-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

calendula officinalis flowering top (12 [hp_C]) ranunculus bulbosus

Inactive Ingredients

cymbopogon martini top lavandula angustifolia flower litsea cubeba fruit melaleuca alternifolia leaf pelargonium graveolens whole

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2013-11-06

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

Description

Calendula officinalis -12C HPUS, Ranunculus bulbosus- 12C HPUS

Medication Information

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

Description

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

Discontinue use if irritation occurs.

Section 50569-3

Consult a doctor if symptoms worsen after 7 days.

Section 53414-9

Do not use if pregnant or breastfeeding.

Section 60561-8

Keep away from eyes and mucous membranes. If swallowed get medical help

or contact a Poison Control Center right away.

Warnings:

For external use only.

Perform skin test prior to initial use.

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.

Indications:

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

Active Ingredients:

Calendula officinalis -12C HPUS,

Ranunculus bulbosus- 12C HPUS

Inactive Ingredients:

Essential Oil Blend (Cymbopogon martinii aerial parts,

Lavandula officinalis flower bud, Litsea cubeba seed,

Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole

plant)

Structured Label Content

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

Description (34089-3)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Discontinue use if irritation occurs.

Section 50569-3 (50569-3)

Consult a doctor if symptoms worsen after 7 days.

Section 53414-9 (53414-9)

Do not use if pregnant or breastfeeding.

Section 60561-8 (60561-8)

Keep away from eyes and mucous membranes. If swallowed get medical help

or contact a Poison Control Center right away.

Warnings:

For external use only.

Perform skin test prior to initial use.

Directions:

Indications:

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

Active Ingredients:

Calendula officinalis -12C HPUS,

Ranunculus bulbosus- 12C HPUS

Inactive Ingredients:

Essential Oil Blend (Cymbopogon martinii aerial parts,

Lavandula officinalis flower bud, Litsea cubeba seed,

Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole

plant)

Advanced Ingredient Data

[{"name": "CYMBOPOGON MARTINI TOP", "unii": "7K1N3UZ6DU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAVANDULA ANGUSTIFOLIA FLOWER", "unii": "19AH1RAF4M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LITSEA CUBEBA FRUIT", "unii": "R3617MQA5Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MELALEUCA ALTERNIFOLIA LEAF", "unii": "G43C57162K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PELARGONIUM GRAVEOLENS WHOLE", "unii": "0E553RP62F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALENDULA OFFICINALIS FLOWERING TOP", "unii": "18E7415PXQ", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "11", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "RANUNCULUS BULBOSUS", "unii": "AEQ8NXJ0MB", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "11", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34089-3": "Dist. by Healing Natural Oils 1042 N El Camino Real, #B-426, Encinitas, CA 92024 USA", "50565-1": "Keep out of reach of children.", "50566-9": "Discontinue use if irritation occurs.", "50569-3": "Consult a doctor if symptoms worsen after 7 days.", "53414-9": "Do not use if pregnant or breastfeeding.", "60561-8": "Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control Center right away.", "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", "Warnings:": "For external use only. Perform skin test prior to initial use.", "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.", "Indications:": "For the treatment of cold sore symptoms, such as fever blisters, soreness at blister site.", "Active Ingredients:": "Calendula officinalis -12C HPUS, Ranunculus bulbosus- 12C HPUS ", "Inactive Ingredients:": "Essential Oil Blend (Cymbopogon martinii aerial parts, Lavandula officinalis flower bud, Litsea cubeba seed, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant)", "Principal Display Panel": "Healing Natural Oils H-Cold Sores Formula Homeopathic For External Use Only 127 11ml (0.37 fl. oz) amoils.com"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:40.642657 · Updated: 2026-03-14T23:17:04.395393