H-Insomnia Formula

Manufacturer
Healing Natural Oils LLC | King Bio Inc
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:31

Label at a glance#

ProductH-Insomnia Formula
Active ingredientCELERY SEED, SAGE
Label structure8 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

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:

INACTIVE INGREDIENT SECTION

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

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of insomnia and sleeplessness.

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

WARNINGS SECTION

For external use only.

Perform skin test prior to initial use.

OTC - PREGNANCY OR BREAST FEEDING SECTION



Do not use if pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Discontinue use if irritation occurs.

OTC - ASK DOCTOR SECTION

Consult a doctor if symptoms worsen after 7 days.

DESCRIPTION SECTION

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

#B-426, Encinitas, CA 92024 USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H-Insomnia

Formula

Homeopathic

For External Use Only

117

11ml (0.37 fl. oz)

amoils.com


H-Insomnia Formula-11ml.jpgH-Insomnia Formula-11ml.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-117-11H-Insomnia Formula11 mL in 1 BOTTLE, DROPPEROIL113
61077-117-33H-Insomnia Formula33 mL in 1 BOTTLE, DROPPEROIL333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-117H-INSOMNIA FORMULA (APIUM GRAVEOLENS, SALVIA OFFICINALIS) OIL [HEALING NATURAL OILS LLC]3Current NDC, Legacy NDC, 2 package rows20241213_e3f5c322-e846-43b6-aa05-5777e6c14a70.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CELERY SEEDACTIVE INGREDIENT1G1EAA320L1
SAGEACTIVE INGREDIENT065C5D077J1
CELERY SEEDACTIVE MOIETY1G1EAA320L1
SAGEACTIVE MOIETY065C5D077J1
CEDRUS ATLANTICA BARK OILINACTIVE INGREDIENTZX5QRE4U601
EUROPEAN HAZELNUT OILINACTIVE INGREDIENT8RQ2839AVG1
LAVANDULA ANGUSTIFOLIA FLOWERING TOPINACTIVE INGREDIENT9YT4B71U8P1
MELISSA OFFICINALISINACTIVE INGREDIENTYF70189L0N1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61077-11761077-117-11, 61077-117-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H-Insomnia FormulaAPIUM GRAVEOLENS, SALVIA OFFICINALISHealing Natural Oils LLCe3f5c322-e846-43b6-aa05-5777e6c14a702024-12-11WarningsExact identifier
ndc (package): 61077-117-11
ndc (package): 61077-117-33
ndc (product): 61077-117
ndc11 (package): 61077011733
ndc11 (package): 61077011711
spl id: 2906c142-d142-b339-e063-6294a90a4b76
spl set id: e3f5c322-e846-43b6-aa05-5777e6c14a70

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.