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

Description

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


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

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)



Principal Display Panel

Healing Natural Oils

H-Cold Sores

Formula

Homeopathic

For External Use Only

127

11ml (0.37 fl. oz)

amoils.com




Structured Label Content

Description (34089-3)

Dist. by Healing Natural Oils 1042 N El Camino Real,

#B-426, Encinitas, CA 92024 USA

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.

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




Advanced Ingredient Data


Raw Label Data

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