The following Structured Product Label (SPL) was submitted to the FDA by Apcco Labs, Inc for the product Sunshine Yeastrelief (NDC 82126-003). 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:, indications:, warnings:, if pregnant or breast feeding..., keep out of reach of children:, directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Thymolum 2X HPUS*.......Antibacterial, antiviral
Chamomilla 2X HPUS*.... Antibacterial, anti-itching
Calendula officinalis 2X HPUS*........Healing Agent
*"HPUS" indicates the active ingredients are in the official Homeopathic
Pharmacopeia of the United States.
Antibacterial, antiviral
Antibacterial, anti-itching
Healing Agent
For the temporary relief of symptoms associated with vaginal yeast infection, including irritation, burning,
itching and discharge.
Warnings
For vaginal use only. Not for oral consumption. Suppository may damage condoms and diaphragms, causing them to fail.
Do not use If you have never had a yeast infection diagnosed by a doctor • If you are allergic to any of the ingredients.
When using this product, do not use tampons, douches, spermicides, or other vaginal products.
Ask a doctor before use If you have vaginal itching and discomfort for the first time • If you have lower abdominal, back, or shoulder pain,
fever,
chills,
nausea,
vomiting or foul-smelling vaginal discharge
• If you have frequent vaginal
yeast
infections (such as once per month or three in six months) • If you have been exposed to sexually transmitted diseases (STDs).
Stop use and ask a doctor If symptoms do not improve within 3 days or last more than 7 days • If you get a rash, hives, abdominal pain, fever, chills, nausea, or vomiting
If pregnant or breast feeding, ask a health professional before use.
If swallowed, get medical help or contact a poison control center immediately at 1-800-222-1222.
Adults 18 years of age and over:
With clean hands, insert one suppository into the vagina. Use the suppository once daily for up to ten days. A thin pad may be used to manage any discharge.
Under 18 years of age: Ask a doctor.
Hydrogenated
Hydroxypropyl
Methylcellulose,
Aloe
Vera
Tetrahexyldecyl Ascorbate (Vitamin C),
Alpha-Tocopherol (Vitamin E).
Store in a cool and dry place away from direct sunlight.
• Do not use if the suppository seal is broken or missing.
Call 844-995-5856
* Please review the disclaimer below.
