H-FISSURES FORMULA - calendula officinalis flowering top and matricaria recutita  oil 
Healing Natural Oils LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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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), Ethanol

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.

If pregnant or breastfeeding consult a doctor before use.


Keep out of reach of children.

Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control
Center right away.

Discontinue use if irritation occurs.

Consult a doctor if symptoms worsen after 7 days.

Dist. by Healing Natural Oils 1042 N El Camino
Real, #B-426, Encinitas, CA 92024 USA

Principal Display Panel

Healing Natural Oils

H-Fissures

Formula

Homeopathic

For External Use Only

036

11ml (0.37 fl. oz)
amoils.com

H-Fissures Label



H-FISSURES FORMULA 
calendula officinalis, chamomilla oil
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61077-036
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP12 [hp_C]  in 11 mL
MATRICARIA RECUTITA ( MATRICARIA RECUTITA ) MATRICARIA RECUTITA 6 [hp_C]  in 11 mL
Inactive Ingredients
Ingredient NameStrength
EUROPEAN HAZELNUT OIL 
HELICHRYSUM ITALICUM FLOWER 
LAVANDULA ANGUSTIFOLIA FLOWER  
CHAMOMILE 
ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61077-036-1111 mL in 1 BOTTLE, DROPPER
2NDC:61077-036-3333 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/06/2013
Labeler - Healing Natural Oils LLC (113679703)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(61077-036)

Revised: 11/2013
Document Id: 5fd1f0c0-906c-4dd4-9cd5-73288c1c7912
Set id: aa2b25cc-5bf3-4aee-951f-497b8ae69f07
Version: 1
Effective Time: 20131104
 
Healing Natural Oils LLC