H-INSOMNIA FORMULA- apium graveolens, salvia officinalis oil

H-Insomnia Formula by

Drug Labeling and Warnings

H-Insomnia Formula by is a Homeopathic medication manufactured, distributed, or labeled by Healing Natural Oils LLC, King Bio Inc, Creations Garden Natural Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Apium graveolens - 6C HPUS
Salvia officinalis - 6C HPUS  

Purpose

Apium graveolens - 6C HPUS (soporific active principle)

Salvia officinalis - 6C HPUS (insomnia and night sweats)

The letters ‘HPUS’ indicate that the components in this product are officially
monographed in the Homoeopathic Pharmacopoeia of the United States

Inactive Ingredients:

Corylus
 avellana
 nut
 oil, 
Essential
 Oil 
Blend
 (Cedrus atlantica   
wood shavings, Lavandula officinalis flower bud, Melissa officinalis blossoms and  
whole plant).

Indications:

For the temporary relief of insomnia and sleeplessness.

Directions:

Adults and Children 4 yrs and over: Wash hands before and after use.
Shake well and apply 1 or 2 drops to fingers and massage temples and back of neck 30 mins before sleep or when needed, no more than 3x per day.
Do not oversaturate or exceed dosage.

Warnings:

For external use only.

Perform skin test prior to initial use.

Do not use if pregnant or breastfeeding.

Keep out of reach of children.

Keep away from eyes and mucous membranes. If swallowed get medical help

or contact a Poison Control Center right away.

Discontinue use if irritation occurs.

Consult a doctor if symptoms worsen after 7 days.

DESCRIPTION

Dist. by Healing Natural Oils 1042 N El Camino Real,

#B-426, Encinitas, CA 92024 USA

Principal Display Panel

Healing Natural Oils

H-Insomnia

Formula

Homeopathic

For External Use Only

117

11ml (0.37 fl. oz)

amoils.com

INGREDIENTS AND APPEARANCE

H-INSOMNIA FORMULA 
apium graveolens, salvia officinalis oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61077-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CELERY SEED (UNII: 1G1EAA320L) (CELERY SEED - UNII:1G1EAA320L)	CELERY SEED	6 [hp_C]  in 11 mL
SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J)	SAGE	6 [hp_C]  in 11 mL

Inactive Ingredients
Ingredient Name	Strength
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
MELISSA OFFICINALIS (UNII: YF70189L0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61077-117-11	11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013
2	NDC: 61077-117-33	33 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/06/2013

Labeler - Healing Natural Oils LLC (113679703)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc		617901350	manufacture(61077-117)