Active Ingredients:
| Apium graveolens - 6C HPUS Salvia officinalis - 6C HPUS |
Sleep Aid Formula Oil
FDA Label NDC 61077-118
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 Sleep Aid Formula (NDC 61077-118). 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
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 & massage temples & 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. |
Otc - Pregnancy Or Breast Feeding
Do not use if pregnant or breastfeeding.
Otc - Keep Out Of Reach Of Children
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
| Discontinue use if irritation occurs. |
Otc - Ask Doctor
Consult a doctor if symptoms worsen after 7 days.
Description
Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA
Package Label.Principal Display Panel
Healing Natural Oils
Sleep Aid
Formula
Homeopathic
For External Use Only
117
11ml (0.37 fl. oz)
amoils.com
* Please review the disclaimer below.
