Active Ingredients:
| Calendula officinalis -12C HPUS Chamomilla - 6C HPUS |
H-fissures Formula Oil
FDA Label NDC 61077-036
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-fissures Formula (NDC 61077-036). 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), Chamomilla - 6C HPUS (soreness of anus, painful fissures). The letters ‘HPUS’ indicate that the components in this product are officially |
Inactive Ingredients:
Corylus avellana nut oil, Essential Oil Blend (Helichrysum
italicum flower, Lavandula officinalis flower
bud, Matricaria recutita flower)
Indications:
For the temporary relief of anal fissure symptoms such as burning, soreness and minor bleeding.
Directions:
Adults and Children 4 yrs and over: Wash hands before and after use.
Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 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
If pregnant or breastfeeding consult a doctor before use.
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-Fissures
Formula
Homeopathic
For External Use Only
036
11ml (0.37 fl. oz)
amoils.com
* Please review the disclaimer below.
