Active Ingredient
Aesculus Hippocastanum 5C - Aloe 5C - Berberis Vulgaris 3C – Capsicum Annuum 5C - Carduus Marianus 3C - Nux Vomica 5C - Pulsatilla 9C.
Comfort Down There Spray
FDA Label NDC 76472-7009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sevene Usa for the product Comfort Down There (NDC 76472-7009). 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 ingredient, traditionally used for, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, storage and handling, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Traditionally Used For
This homeopathic medicine is made from a combination of ingredients traditionally used to Relieve Symptoms of Hemorrhoids:
- Soreness, Tenderness, Burning, Itching
- Constipation
- Pain after Bowel Movements
Dosage & Administration
Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Indications & Usage
AESCULUS HIPPOCASTANUM
Hemorrhoids Pain - Venous Congestion .*
ALOE
Hemorrhoids - Urgent Diarrhea .*
BERBERIS VULGARIS
Radiating, Painful, Frequent urination - Skin rash with round, red patches and
thin flakes .*
CAPSICUM ANNUUM
Stuffy, Runny Nose with Sneezing and Post Nasal Drip - Sore Throat with Burning Pain .*
CARDUUS MARIANUS
Hemorrhoids .*
NUX VOMICA
Indigestion, Heartburn, Drowsiness after Meals, Nausea from Overindulgence/Overeating .*
PULSATILLA
Ocular or Nasal Yellow Discharge Associated with Cold .*
Warnings
Consult a physician for use in children under 6 years of age.
Contact a doctor if symptoms persist.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Storage And Handling
Store at 59-77°F.
Otc - Do Not Use
Do not use if seal is broken or missing.
Inactive Ingredient
Organic Alcohol 20%
Purified Water
Questions?
Distributed by Sevene USA
East Troy, WI 53120 USA
1-855 - OLLOMED
QUESTIONS? [email protected]
www.ollois.com
MADE IN FRANCE.
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. No guarantee to be effective. A homeopathic dilution may not to be susceptible to scientific measurement. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
* Please review the disclaimer below.
