Active Ingredient(S)
Boricum Acidum
Canagyn
FDA Label NDC 82349-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Palcare Enterprises Inc for the product Canagyn (NDC 82349-120). 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(s), purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, 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
Antifungal
Use
Uses: Helps reduce the overgrowth of recurrent or resistant vaginal yeast. Relieve recurrent vaginal infections such as candidiasis. Helps to reduce the incidence of recurrent Vulvovaginal Candidiasis. Relieves secretions associated with vaginitis. Helps to treat symptoms of recurrent Yeast Vaginitis and Vulvovaginal Candidiasis.
Warnings
Not for oral use. There is enough boron in this package to cause serious harm if ingested.
Consult a health care practitioner if symptoms persist or worsen.
Consult a health care practitioner prior to use if you have been diagnosed with estrogen-dependent cancer or if you have a kidney disorder
Otc - Do Not Use
Do not use if you are pregnant or breastfeeding.
Otc - When Using
Consult a health care practitioner if symptoms persist or worsen.
Consult a health care practitioner prior to use if you have been diagnosed with estrogen-dependent cancer or if you have a kidney disorder
Otc - Stop Use
Discontinue use and consult a healthcare practitioner if you experience vaginal pain, irritation or burning. Symptoms such as burning sensation, watery discharge, and erythema have been known to occur.
Otc - Keep Out Of Reach Of Children
Store in a safe place. if ingested, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
Insert 1 suppository per day into the vagina before bedtime for 14 consecutive days.
Other Information
- Boric acid has mild antiseptic and anti-fungal actions. This product is a homeopathic OTC medicine used to treat vaginal yeast infections and relieve symptoms such as burning, itching, and odor.
- Avoid having sexual intercourse while you are treating a vaginal infection.
- Do not use tampons, douches, or spermicides products while using this product.
- Store it between 15 - 25 °C (59 - 77 °F).
Canagyn will not prevent an infection from spreading to your partner. This medicine will not treat or prevent sexually transmitted diseases.
Inactive Ingredients
Hydrogenated Coco-glycerides, Ceteareth-25, Glyceryl Ricinolate, Sodium Lactate (L-Lactic Acid), Lactic
Acid
* Please review the disclaimer below.
