H-insomnia Formula Oil
FDA Label NDC 61077-117

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healing Natural Oils Llc for the product H-insomnia Formula (NDC 61077-117). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, purpose, inactive ingredients:, indications:, directions:, warnings:, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.



Description

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

#B-426, Encinitas, CA 92024 USA

* Please review the disclaimer below.