HYLAFEM

Manufacturer
U.S. PHARMACEUTICAL CORPORATION
Effective date
2022-11-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:36

Label at a glance#

ProductHYLAFEM BORICUM ACIDUM 3X
Active ingredientBORIC ACID
Label structure12 sections

Indications and uses

 treats and relieves symptoms of vaginal and urinary infections  rebalances vaginal pH and restores normal vaginal health  helps relieve symptoms of external and internal vaginal burning, itching, irritation and dryness  helps reduce vaginal odor due to vaginal infections

Label contents#

Full prescribing information#

Active ingredient                                                            Purpose

OTC - ACTIVE INGREDIENT SECTION

Boricum Acidum 3X* HPUS**                               Restores vaginal pH and relieves

                                                                                vaginal itching, burning and irritation.

*X is a homeopathic dilution. **The letters HPUS indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

 treats and relieves symptoms of vaginal and urinary infections
 rebalances vaginal pH and restores normal vaginal health
 helps relieve symptoms of external and internal vaginal burning, itching, irritation and dryness
 helps reduce vaginal odor due to vaginal infections

WARNINGS SECTION

Warnings
For vaginal use only
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
vaginal itching and discomfort for the first time
 lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
 vaginal yeast infection often (such as once a month or 3 in 6 months). You could be pregnant or a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
 been exposed to human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

OTC - WHEN USING SECTION

When using this product
 do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexual transmitted disease (STDs).
 do not have vaginal intercourse
 mild increase in vaginal burning, itching or irritation may occur
 if you do not get complete relief ask a doctor before using another product

OTC - STOP USE SECTION

Stop use and ask a doctor if
 symptoms do not get better in 3 days
 symptoms last more than 7 days
 you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

HOW SUPPLIED SECTION

How supplied, storage and handling
Hylafem pH is supplied in a clear natural plantcap capsule in three (3) individual foil packets of one (1) capsule each, NDC # 52747-0255-03 with three (3) disposable vaginal applicators in each carton. Avoid sunlight and store unopened pouches at 15˚ to 30˚ C (59˚ to 86˚ F)

DOSAGE & ADMINISTRATION SECTION

Other information
 Hylafem pH is not a contraceptive and should not be used to prevent pregnancy or to prevent or treat sexually transmitted diseases (STDs).
 do not use if suppository pouch seal is compromised
 do not use if seal over applicator has been punctured
 do not purchase if carton is open

SPL UNCLASSIFIED SECTION

Directions
 before using this product, read all consumer information provided on carton and insert
Adults and children 12 years of age and over:
 place vaginal capsule suppository in applicator and gently insert into the vagina.
 for acute infection, use one (1) capsule suppository a day for three (3) days
 for chronic infection, use an additional package of three (3) vaginal capsule suppositories
 throw applicator away after each use
children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients
Maltodextrin, Antioxidants-Vitamin E (DL-Alpha-Tocopheryl Acetate) & Vitamin C (Ascorbic Acid), Lactobacillus casei (KE-99), Lactobacillus gasseri and Capsule Ingredient (Pullulan).

ADVERSE REACTIONS SECTION

Adverse reactions and side effects
The adverse effects are considered mild and may include watery discharge, erythema, or slight burning sensation.
You should contact your healthcare provider for medical advice about adverse events or report a serious adverse event, by contacting US Pharmaceutical Corporation at the address listed below.

Distributed by:
US Pharmaceutical Corporation
2443 Park Central Blvd
Decatur, GA 30035, USA

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52747-255-03HYLAFEMBORICUM ACIDUM 3X1 in 1 CARTONSUPPOSITORY15
52747-255-03HYLAFEMBORICUM ACIDUM 3X3 in 1 CAPSULESUPPOSITORY35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52747-255HYLAFEM BORICUM ACIDUM 3X (BORICUM ACIDUM) SUPPOSITORY [U.S. PHARMACEUTICAL CORPORATION]5Current NDC, Legacy NDC, 2 package rows20221119_fcd50c95-2522-418f-a2f3-de7e22622363.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52747-255-03EA - Each52747-2552ae73dfe-cb48-4f14-99ee-656ca4c0b37912020-09-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52747-25552747-255-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYLAFEM BORICUM ACIDUM 3XBORICUM ACIDUMU.S. PHARMACEUTICAL CORPORATIONfcd50c95-2522-418f-a2f3-de7e226223632022-11-17Warnings, Adverse reactionsExact identifier
ndc (package): 52747-255-03
ndc (product): 52747-255
ndc11 (package): 52747025503
spl id: 108fa2fe-f7a1-4c68-927e-70ef523e81d0
spl set id: fcd50c95-2522-418f-a2f3-de7e22622363

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.