a48cbe3b-2e19-4bdf-9720-a37100130194

SPL v3
SPL
SPL Set ID a48cbe3b-2e19-4bdf-9720-a37100130194
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]) thuja occidentalis leafy twig
Inactive Ingredients
european hazelnut oil bergamot oil lavandula angustifolia flowering top melaleuca alternifolia leaf pelargonium graveolens whole

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2013-11-06

Purpose

Calendula
 officinalis
  - ­
12C 
HPUS 
(healing 
agent),
 Thuja
 occidentalis - 
­12C 
HPUS 
(for
 fungus) 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
, Thuja
 occidentalis
­ - 12C
 HPUS



Medication Information

Purpose
Calendula
 officinalis
  - ­
12C 
HPUS 
(healing 
agent),




Thuja
 occidentalis - 
­12C 
HPUS 
(for
 fungus)





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-Jock Itch

Formula

Homeopathic

For External Use Only

088

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 jock itch symptoms such as itching, redness and irritation.



Active Ingredients:
Calendula
 officinalis
 - ­
12C
 HPUS
,



Thuja
 occidentalis
­ - 12C
 HPUS



Inactive Ingredients:
Corylus
 avellana
 nut
 oil, 
Essential
 Oil 
Blend
 (Citrus 
bergamia


peel, 
Lavandula
 officinalis
 flower 
bud,


Melaleuca
 alternifolia 
leaf-­branch,


Pelargonium
 graveolens 
whole 
plant).



Structured Label Content

Purpose
Calendula
 officinalis
  - ­
12C 
HPUS 
(healing 
agent),




Thuja
 occidentalis - 
­12C 
HPUS 
(for
 fungus)





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 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-Jock Itch

Formula

Homeopathic

For External Use Only

088

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.

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 jock itch symptoms such as itching, redness and irritation.



Active Ingredients:
Calendula
 officinalis
 - ­
12C
 HPUS
,



Thuja
 occidentalis
­ - 12C
 HPUS



Inactive Ingredients:
Corylus
 avellana
 nut
 oil, 
Essential
 Oil 
Blend
 (Citrus 
bergamia


peel, 
Lavandula
 officinalis
 flower 
bud,


Melaleuca
 alternifolia 
leaf-­branch,


Pelargonium
 graveolens 
whole 
plant).



Advanced Ingredient Data


Raw Label Data

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