Hylafem Ph Homeopathic Vaginal Suppositories

Hylafem Ph Homeopathic Vaginal Suppositories
SPL v5
SPL
SPL Set ID fcd50c95-2522-418f-a2f3-de7e22622363
Route
VAGINAL
Published
Effective Date 2020-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Boric Acid (3 [hp_X])
Inactive Ingredients
Maltodextrin .alpha.-tocopherol Acetate Ascorbic Acid Lacticaseibacillus Casei Lactobacillus Gasseri

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-12-09

Description

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.

Purpose

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.


Medication Information

Warnings and Precautions

Warnings

For vaginal use only

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

Purpose

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.

Dosage and 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

Dosage Forms and Strengths

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)

Description

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

 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

Section 34084-4

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

Section 42229-5

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

Section 50566-9

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.

Section 50567-7

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

Section 50569-3

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.

Section 51727-6

Inactive ingredients

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

Product Label

Active Ingredient                                                            Purpose

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.


Structured Label Content

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

Dosage and Administration (34068-7)

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

Dosage Forms and Strengths (34069-5)

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)

Warnings and Precautions (34071-1)

Warnings

For vaginal use only

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

Section 34084-4 (34084-4)

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

Section 42229-5 (42229-5)

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

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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.

Section 51727-6 (51727-6)

Inactive ingredients

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

Product Label (Product label)

Active Ingredient                                                            Purpose (Active ingredient                                                            Purpose)

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.


Advanced Ingredient Data


Raw Label Data

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