SPL v2
SPL
SPL Set ID a6f59c34-e252-4458-8ce4-01e2d3028aa8
Route
TOPICAL
Published
Effective Date 2017-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (12 [hp_C]) Hamamelis Virginiana Root Bark/stem Bark (6 [hp_C])
Inactive Ingredients
European Hazelnut Oil Helichrysum Italicum Flower Chamomile Pelargonium Graveolens Whole

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-11-06

Description

Calendula officinalis -12C HPUS Hamamelis virginiana - 6C HPUS 

Purpose

Calendula officinalis - 12C HPUS (healing agent), Hamamelis virginiana - 6C HPUS (anus raw, bleeding). 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),

Hamamelis virginiana - 6C HPUS (anus raw, bleeding).





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-BI Hemorrhoids

Formula

Homeopathic

For External Use Only

005

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.

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 or your finger and apply directly to the affected area 3x per day.

Do not oversaturate or exceed dosage.

Indications:

For the temporary relief of hemorrhoid symptoms such as burning,

soreness and minor bleeding

Active Ingredients:

Calendula officinalis -12C HPUS

Hamamelis virginiana - 6C HPUS 

Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Helichrysum italicum flower,

Matricaria recutita flower, Pelargonium graveolens whole plant)


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-BI Hemorrhoids

Formula

Homeopathic

For External Use Only

005

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),

Hamamelis virginiana - 6C HPUS (anus raw, bleeding).





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 or your finger and apply directly to the affected area 3x per day.

Do not oversaturate or exceed dosage.

Indications:

For the temporary relief of hemorrhoid symptoms such as burning,

soreness and minor bleeding

Active Ingredients:

Calendula officinalis -12C HPUS

Hamamelis virginiana - 6C HPUS 

Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Helichrysum italicum flower,

Matricaria recutita flower, Pelargonium graveolens whole plant)


Advanced Ingredient Data


Raw Label Data

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