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NDC 42346-0501-59 Frankincense and Myrrh Sciatica 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Details

Frankincense and Myrrh Sciatica 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL

Frankincense and Myrrh Sciatica is a TOPICAL OIL in the HUMAN OTC DRUG category. It is labeled and distributed by Wise Consumer Products Co.. The primary component is ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM.

Product Information

NDC	42346-0501
Product ID	42346-501_4d471d7e-f710-48c8-858d-aeae59a5cabb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Frankincense and Myrrh Sciatica
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aconitum napellus, Bryonia alba, Hypericum perforatum
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	TOPICAL
Active Ingredient Strength	3; 3; 3
Active Ingredient Units	[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Substance Name	ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM
Labeler Name	Wise Consumer Products Co.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 42346-0501-59 (42346050159)

Pricing Information	N/A
NDC Package Code	42346-501-59
Billing NDC	42346050159
Package	1 BOTTLE, DROPPER in 1 CARTON (42346-501-59) / 59 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2017-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3f2c7912-4f1f-40c4-a077-7c3377ef4e1e Details

Active Ingredients

Aconitum napellus 3X HPUS

Bryonia alba 3X HPUS

Hypericum perforatum 3X HPUS

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Aconitum napellus 3X HPUS...................Minor Pain Reliever

Bryonia alba 3X HPUS............................Anti-inflammatory

Hypericum perforatum 3X HPUS.............Topical Analgesic

Uses:

For temporary relief of the symptoms of sciatica and lower back pain such as: pain numbness tingling weakness As per Homeopathic Materia Medica

Warnings:

For external use only.

Do not

apply to wounds, broken or damaged skin
apply over large areas of the body

When using this product

avoid contact with eyes, mouth, nose or mucous membranes
do not bandage tightly

Stop use and ask a doctor if

you are experiencing nerve pain in the feet and hands that includes burning, shooting, prickling/tingling pains, numbness or itching as these can be signs of diabetic neuropathy. See a healthcare professional regularly if you have or suspect you have these symptoms.
condition worsens
if symptoms persist for more than 7 days or clear up and occur again within a few days
excessive skin irritation occurs

If pregnant or breastfeeding, ask a health care professional before use.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions:

Adults and children 12 years of age and older: apply 10-40 drops in palm or hand and massage into lower back and affected areas
massage oil in hand to coat painful areas
can be used up to 4 times daily
children under 12 years of age: consult a physician

Other Information:

store at room temperature.
tamper resistant: do not use if seal around the neck of bottle is broken or missing.
keep carton, it contains important information.

Inactive Ingredients:

Boswellia Carterii (Frankincense) Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Commiphora Myrrha (Myrrh) Oil, Eucalyptus Globulus Leaf Oil, Helianthus Annuus (Sunflower) Seed Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Mentha Piperita (Peppermint) Oil, Pelargonium Graveolens (Geranium) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol.

Questions or comments?

1-877-917-9674 or www.frankincensemyrrh.com

SPL UNCLASSIFIED SECTION

Manufactured in New Hampshire for: Wise Consumer Products Co. PO Box 42400 Cincinnati, OH 45242 www.frankincensemyrrh.com Keep this carton - it contains important information Temporarily relieves the pain of SCIATICA Frankincense and MyrrhTM Sciatica is specifically formulated to deliver temporary and topical relief for sciatica and lower back pain. The plant extract formula blends homeopathic ingredients in a base of sunflower oil and 10 essential oils. Blended in an FDA registered and inspected facility in the United States.

Reclaim Your Life!

PLANT EXTRACTS

SCIATICA

Proprietary Formula based on the healing qualities of 3 homeopathic ingredients with the soothing scent of 10 essentila oils.
Provides temporary topical relief from sciatica and lower back pain.
Use up to four times a day.

PRINCIPAL DISPLAY PANEL

NDC 42346-501-59 TEMPORARY PAIN RELIEF -Relief for lower back and legs Frankincense and MyrrhTM Reclaim Your Life! TEMPORARY SCIATICA AND LOWER BACK RELIEF ANALGESIC and ANTI-INFLAMMATORY TOPICAL RELIEF Temporary Pain Relief - Analgesic - Anti- Inflammatory SCIATICA Homeopathic RUBBING OIL 2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

FRANKINCENSE AND MYRRH SCIATICA

aconitum napellus, bryonia alba, hypericum perforatum oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42346-501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X] in 59 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_X] in 59 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 59 mL

Ingredient Name	Strength
Inactive Ingredients
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
CINNAMON LEAF OIL (UNII: S92U8SQ71V)
BERGAMOT OIL (UNII: 39W1PKE3JI)
LEMON OIL (UNII: I9GRO824LL)
MYRRH OIL (UNII: H74221J5J4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SUNFLOWER OIL (UNII: 3W1JG795YI)
NUTMEG OIL (UNII: Z1CLM48948)
PEPPERMINT OIL (UNII: AV092KU4JH)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
ROSEMARY OIL (UNII: 8LGU7VM393)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42346-501-59	1 in 1 CARTON	06/01/2017
1		59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2017

Labeler - Wise Consumer Products Co. (006459643)

Name	Address	ID/FEI	Business Operations
Establishment
PJ Noyes Co. Inc.		018927392	manufacture(42346-501)

Revised: 5/2017

Document Id: 4d471d7e-f710-48c8-858d-aeae59a5cabb

Set id: 3f2c7912-4f1f-40c4-a077-7c3377ef4e1e

Version: 1

Effective Time: 20170531