Label: HYLAFEM BORICUM ACIDUM 3X- boricum acidum suppository
- NDC Code(s): 52747-255-03
- Packager: U.S. PHARMACEUTICAL CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated November 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- Uses
- WARNINGS
-
ASK DOCTOR
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 AIDSAsk a doctor or pharmacist before use if you are taking prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
-
WHEN USING
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 -
STOP USE
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
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
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
-
ADVERSE REACTIONS
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
-
INGREDIENTS AND APPEARANCE
HYLAFEM BORICUM ACIDUM 3X
boricum acidum suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52747-255 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID 3 [hp_X] Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) LACTICASEIBACILLUS CASEI (UNII: SA940P2U00) LACTOBACILLUS GASSERI (UNII: Q66E0D2443) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52747-255-03 1 in 1 CARTON 12/09/2019 1 3 in 1 CAPSULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/09/2019 Labeler - U.S. PHARMACEUTICAL CORPORATION (079467662)