SPL v2
SPL
SPL Set ID 9f9ea8b1-2dd7-46b3-9f8f-5668f0279f00
Route
TOPICAL
Published
Effective Date 2017-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (12 [hp_C]) Bellis Perennis (30 [hp_C]) Matricaria Recutita (6 [hp_C])
Inactive Ingredients
European Hazelnut Oil Frankincense Oil Palmarosa Oil Lavandula Angustifolia Flowering Top Peppermint Rosmarinus Officinalis Whole Sesame Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-02-19

Description

Arnica Montana 12C HPUS, Bellis perennis 30C HPUS, Chamomilla 6C HPUS

Purpose

Arnica Montana 12C HPUS (Muscular tonic. Pain in back and limbs), Bellis perennis 30C HPUS (Joints muscular soreness), Chamomilla 6C HPUS (Lumbago. Stiffness of neck muscles) The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States


Medication Information

Purpose

Arnica Montana 12C HPUS (Muscular tonic. Pain in back and limbs), Bellis perennis 30C HPUS (Joints muscular soreness), Chamomilla 6C HPUS (Lumbago. Stiffness of neck muscles)

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-Joint & Muscle

Formula

Homeopathic

For External Use Only

137

11ml (0.37 fl. oz)

amolis.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 years and over:  Wash hands before and after use. Shake well and apply a few drops to fingers and massage directly to the affected area 3x per day. Do not oversaturate or exceed dosage.

Indications:

For the temporary relief of joint and muscle pain.

Active Ingredients:

Arnica Montana 12C HPUS, Bellis perennis 30C HPUS, Chamomilla 6C HPUS

Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Boswellia carterii oleo-gum-resin, Cymbopogon martinii aerial parts, Lavandula officinalis flower bud, Mentha piperita flower and whole plant, Rosmarinus officinals whole plant), 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-Joint & Muscle

Formula

Homeopathic

For External Use Only

137

11ml (0.37 fl. oz)

amolis.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

Arnica Montana 12C HPUS (Muscular tonic. Pain in back and limbs), Bellis perennis 30C HPUS (Joints muscular soreness), Chamomilla 6C HPUS (Lumbago. Stiffness of neck muscles)

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 years and over:  Wash hands before and after use. Shake well and apply a few drops to fingers and massage directly to the affected area 3x per day. Do not oversaturate or exceed dosage.

Indications:

For the temporary relief of joint and muscle pain.

Active Ingredients:

Arnica Montana 12C HPUS, Bellis perennis 30C HPUS, Chamomilla 6C HPUS

Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Boswellia carterii oleo-gum-resin, Cymbopogon martinii aerial parts, Lavandula officinalis flower bud, Mentha piperita flower and whole plant, Rosmarinus officinals whole plant), Sesamum indicum seed oil.


Advanced Ingredient Data


Raw Label Data

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