SPL v4
SPL
SPL Set ID aa2b25cc-5bf3-4aee-951f-497b8ae69f07
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]) Matricaria Recutita (6 [hp_C])
Inactive Ingredients
European Hazelnut Oil Helichrysum Italicum Flower Lavandula Angustifolia Flower Chamomile

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-11-06

Description

Calendula officinalis -12C HPUS    Chamomilla - 6C HPUS

Purpose

Calendula officinalis - 12C HPUS (healing agent), Chamomilla - 6C HPUS (soreness of anus, painful fissures). 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),

Chamomilla - 6C HPUS (soreness of anus, painful fissures).



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-Fissures

Formula

Homeopathic

For External Use Only

036

11ml (0.37 fl. oz)

amoils.com

Section 53414-9

If pregnant or breastfeeding consult a doctor before use.

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 anal fissure symptoms such as burning, soreness and minor bleeding.

Active Ingredients:
Calendula officinalis -12C HPUS   

Chamomilla - 6C HPUS


Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Helichrysum

italicum flower, Lavandula officinalis flower

bud, Matricaria recutita flower)


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-Fissures

Formula

Homeopathic

For External Use Only

036

11ml (0.37 fl. oz)

amoils.com

Section 53414-9 (53414-9)

If pregnant or breastfeeding consult a doctor before use.

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),

Chamomilla - 6C HPUS (soreness of anus, painful fissures).



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 anal fissure symptoms such as burning, soreness and minor bleeding.

Active Ingredients:
Calendula officinalis -12C HPUS   

Chamomilla - 6C HPUS


Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Helichrysum

italicum flower, Lavandula officinalis flower

bud, Matricaria recutita flower)


Advanced Ingredient Data


Raw Label Data

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