SPL v4
SPL
SPL Set ID e02194ec-cfa7-4f36-be02-a53b1e80a235
Route
TOPICAL
Published
Effective Date 2017-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (12 [hp_C]) Phytolacca Americana Root Thuja Occidentalis Leafy Twig
Inactive Ingredients
Lavandula Angustifolia Flowering Top Melaleuca Alternifolia Leaf Melissa Officinalis Thuja Occidentalis Leaf Sesame Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-11-06

Description

Calendula officinalis - 12C HPUS Phytolacca decandra - 12C HPUS Thuja occidentalis - 12C HPUS

Purpose

Calendula officinalis -12C HPUS (healing agent),  Phytolacca decandra - 12C HPUS (for moles), Thuja occidentalis - 12C HPUS (acts on skin, moles) 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 (healing agent), 

Phytolacca decandra - 12C HPUS (for moles),

Thuja occidentalis - 12C HPUS (acts on skin, moles)

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 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, 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 51945-4

Healing Natural Oils

H-Moles

Formula

Homeopathic

For External Use Only

125

11ml (0.37 fl. oz)

amoils.com

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.

Only use on benign skin moles.

Perform skin test prior to initial use.

Directions:

Adults and children 4 years and over:  Wash hands before and after use.

Shake well and apply 1 or 2 drops to a cotton swab and dab directly to the moles 3x daily.

Do not oversaturate or exceed dosage.

Indications:

Symptomatic treatment of benign skin moles

Active Ingredients:

Calendula officinalis - 12C HPUS

Phytolacca decandra - 12C HPUS

Thuja occidentalis - 12C HPUS



Inactive Ingredients:

Essential Oil Blend (Lavandula officinalis flower bud, Melaleuca

alternifolia leaf-branch, Melissa officinalis blossoms and whole plant,

Thuja occidentalis leaf), Sesamum Indicum seed oil


Structured Label Content

Description (34089-3)

Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, 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 51945-4 (51945-4)

Healing Natural Oils

H-Moles

Formula

Homeopathic

For External Use Only

125

11ml (0.37 fl. oz)

amoils.com

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 (healing agent), 

Phytolacca decandra - 12C HPUS (for moles),

Thuja occidentalis - 12C HPUS (acts on skin, moles)

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.

Only use on benign skin moles.

Perform skin test prior to initial use.

Directions:

Adults and children 4 years and over:  Wash hands before and after use.

Shake well and apply 1 or 2 drops to a cotton swab and dab directly to the moles 3x daily.

Do not oversaturate or exceed dosage.

Indications:

Symptomatic treatment of benign skin moles

Active Ingredients:

Calendula officinalis - 12C HPUS

Phytolacca decandra - 12C HPUS

Thuja occidentalis - 12C HPUS



Inactive Ingredients:

Essential Oil Blend (Lavandula officinalis flower bud, Melaleuca

alternifolia leaf-branch, Melissa officinalis blossoms and whole plant,

Thuja occidentalis leaf), Sesamum Indicum seed oil


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)