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NDC 52747-0255-03 HYLAFEM 3 [hp_X]/1 Details
HYLAFEM 3 [hp_X]/1
HYLAFEM is a VAGINAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by U.S. PHARMACEUTICAL CORPORATION. The primary component is BORIC ACID.
Product Information
NDC | 52747-0255 |
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Product ID | 52747-255_108fa2fe-f7a1-4c68-927e-70ef523e81d0 |
Associated GPIs | 99870010005250 |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | HYLAFEM |
Proprietary Name Suffix | BORICUM ACIDUM 3X |
Non-Proprietary Name | Boricum Acidum |
Product Type | HUMAN OTC DRUG |
Dosage Form | SUPPOSITORY |
Route | VAGINAL |
Active Ingredient Strength | 3 |
Active Ingredient Units | [hp_X]/1 |
Substance Name | BORIC ACID |
Labeler Name | U.S. PHARMACEUTICAL CORPORATION |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED HOMEOPATHIC |
Application Number | n/a |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 52747-0255-03 (52747025503)
NDC Package Code | 52747-255-03 |
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Billing NDC | 52747025503 |
Package | 1 CAPSULE in 1 CARTON (52747-255-03) / 3 SUPPOSITORY in 1 CAPSULE |
Marketing Start Date | 2019-12-09 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL fcd50c95-2522-418f-a2f3-de7e22622363 Details
Active ingredient Purpose
Uses
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED 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
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED 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)
SPL UNCLASSIFIED 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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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
INGREDIENTS AND APPEARANCE
HYLAFEM
BORICUM ACIDUM 3X
boricum acidum suppository |
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Labeler - U.S. PHARMACEUTICAL CORPORATION (079467662) |