Pharmlitalia Vaginal Symptoms Relief Gel
FDA Label NDC 87947-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Trading Financing Union Llc for the product Pharmlitalia Vaginal Symptoms Relief (NDC 87947-001). 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 (per applicator)....................................purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (Per Applicator)....................................Purpose

Borax 3X HPUS (Sodium Borate)                                         Homeopathic*
Calendula officinalis 1X HPUS                                              Homeopathic*
Hydrastis canadensis 5X HPUS                                            Homeopathic*
Olive Extract (Oleuropein) 3X HPUS                                     Homeopathic*

*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

For the temporary relief of minor vaginal discomfort and feelings of irritation.

Warnings

For vaginal use only. Do not swallow;   For adult use only.


Donot use:
• if you have never had vaginal symptoms before
• if you are allergic to any of the ingredients in this product
• if you have fever, chills, abdominal pain, or pelvic pain
• if you have abnormal vaginal bleeding
• if the applicator wrapper or seal is damaged, torn, or shows incomplete seals


Ask a doctor before use if you have:
• diabetes, a weakened immune system, or a history of recurrent vaginal infections
• a serious medical condition or are under medical supervision
• symptoms that have lasted more than 7 days before starting use


When using this product:
• you may experience mild burning, itching, or irritation at the application site
• do not use tampons, douches, spermicides, or other vaginal products
• this product may damage condoms and diaphragms and reduce their effectiveness
• avoid contact with eyes


Stop use and ask a doctor if:
• symptoms do not improve within 3 days
• symptoms last more than 7 days
• symptoms worsen or return after completion
• new symptoms develop, including fever, rash, pelvic pain, nausea, or unusual bleeding
• severe burning, swelling, or rash occurs at the application site


If pregnant or breastfeeding, ask a healthcare professional before use.


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
right away (1-800-222-1222).

Directions

• adults: insert one (1) applicator vaginally at bedtime
• use once daily for up to 7 consecutive nights
• do not use more than one applicator in any 24-hour period
• children under 12 years: ask a doctor

Other Information

• do not use if foil pouch or seal is damaged or previously opened
• store at 20–25 °C (68–77 °F); excursions permitted to 15–30 °C (59–86 °F)
• protect from direct heat and sunlight
• do not refrigerate unless product softens or loses shape

Inactive Ingredients

Chamomilla Recutita (Chamomile) Extract, Chitosan, Collagen Peptide,Curcuma Zedoaria Extract, Oxygenated Olive Oil, Radix Curcumae Extract,
Rhizoma Sparganii Extract, Sodium Hyaluronate, Sophora Flavescens (Kuh-seng) Extract.


*Claims based on traditional homeopathic practice and not on modern scientific evidence.

Product Label

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* Please review the disclaimer below.