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  5. Label Information: H-fissures Formula

FDA Label for H-fissures Formula

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE
    3. INACTIVE INGREDIENTS:
    4. INDICATIONS:
    5. DIRECTIONS:
    6. WARNINGS:
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTHER SAFETY INFORMATION
    10. OTC - STOP USE
    11. OTC - ASK DOCTOR
    12. DESCRIPTION
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-fissures Formula Product Label

The following document was submitted to the FDA by the labeler of this product Healing Natural Oils Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:



Calendula officinalis -12C HPUS   
Chamomilla - 6C HPUS


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
monographed in the Homoeopathic Pharmacopoeia of the United States



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.