Active Ingredients:
Calendula officinalis - 12C HPUS Phytolacca decandra - 12C HPUS |
H-moles Formula Oil
FDA Label NDC 61077-125
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-moles Formula (NDC 61077-125). 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
| Calendula officinalis -12C HPUS (healing agent), Phytolacca decandra - 12C HPUS (for moles), Thuja occidentalis - 12C HPUS (acts on skin, moles) The letters ‘HPUS’ indicate that the components in this product are officially |
Inactive Ingredients:
Essential Oil Blend (Lavandula officinalis flower bud, Melaleuca
alternifolia leaf-branch, Melissa officinalis blossoms and whole plant,
Thuja occidentalis leaf), Sesamum Indicum seed oil
Indications:
Symptomatic treatment of benign skin moles
Directions:
Adults and children 4 years and over: Wash hands before and after use.
Shake well and apply 1 or 2 drops to a cotton swab and dab directly to the moles 3x daily.
Do not oversaturate or exceed dosage.
Warnings:
For external use only.
Only use on benign skin moles.
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-Moles
Formula
Homeopathic
For External Use Only
125
11ml (0.37 fl. oz)
amoils.com
* Please review the disclaimer below.
