Active Ingredients:
| Apium graveolens - 12C HPUS Nux vomica -12C HPUS |
H-headaches Formula Oil
FDA Label NDC 61077-038
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-headaches Formula (NDC 61077-038). 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 - 12C HPUS (throbbing headaches), Nux vomica -12C HPUS (headache in occiput or over eyes) 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 (Citrus limon peel,
Lavandula officinalis flower bud, Matricaria
recutita flower, Mentha piperita flower and
whole plant, Rosmarinus officinalis whole
plant).
Indications:
For the temporary relief of headache symptoms such as throbbing pain, pain above the eyes.
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 every 30mins or when needed, no more than 5x 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
H-Headaches
Formula
Homeopathic
For External Use Only
038
11ml (0.37 fl. oz)
amoils.com
* Please review the disclaimer below.
