SPL v2
SPL
SPL Set ID de4dc2a2-b829-4b1b-8813-94700315a7bc
Route
VAGINAL
Published
Effective Date 2018-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hamamelis Virginiana Root Bark/stem Bark (6 [hp_X]) Collinsonia Canadensis Root (3 [hp_X]) Borate Ion Berberis Vulgaris Root Bark
Inactive Ingredients
Propanediol Xanthan Gum Sodium Hydroxide Sodium Benzoate Gluconolactone Edetic Acid Allantoin, (+)- Benzalkonium Chloride Water Polysorbate 20 Tea Tree Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-04-01

Description

Borax 3X HPUS Collinsonia Canadensis 3X HPUS Berberis Vulgaris 6X HPUS Hamamelis Virginiana 6X HPUS


Medication Information

Indications and Usage

Uses For temporary relief of symptoms associate with vaginal yeast infection, including:itching, burning, and irritation.

Description

Borax 3X HPUS Collinsonia Canadensis 3X HPUS Berberis Vulgaris 6X HPUS Hamamelis Virginiana 6X HPUS

Section 50565-1

Keep out of reach of children. If swallowed, get medial help or contact a Poison Control Center right away. If in eyes, flush with water for 15 minutes and call a physician.

Section 50566-9

Stop use and ask doctor if

  • Symptoms worsen, last more than 7 days, or clear up and occur again within a few days.
  • You get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
Section 50567-7

When using this product

  • Wash hands thoroughly with soap and water before and after use
  • Avoid contact with eyes
  • If burning sensation occurs and lasts more than a few minutes, remove gel and discontinue use
  • Do not use more than one week unless directed by a doctor
  • If yoyu 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 serious condition.
  • Vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for you symptoms, including diabetes or a weakened immune system.
  • Been exposed to the human immunodeficiency virus (HIV) that causes AIDS
  • You have an STD (sexually transmitted disease) or PID (Pelvic inflammatory disease)
  • You have frequent and painful urination
Section 50570-1

Do not use if

  • you have never had a vaginal yeast infection diagnosed by a doctor.

Section 51945-4

Section 53413-1

Questions or comments? 1-800-635-3696

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose Temporary relief from external vagianl discomfort including itching, burning, and irritation

Warnings

For external vaginal use only. Use only as directed.

Directions

Directions

  • Apply to affected area as often as needed. Because the area is irritated, you could experience a slight burning sensation. If this persists more than a few minutes, remove gel and discontinue use.
  • Wash hand thoroughly with soap an dwater before and after use.
  • Do not use for children under two years. Consult a doctor if condition persists.
Other Information

Other information

  • Do not use if safety seal under cap is missing or broken
  • Store at room temperature
  • Lot number and expiration date: see date on tube and box flap.
  • Retain carton for complete Drug Facts Warnings
  • There is no scientific evidence that this product works. Ther product claims are based on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Active Ingredients

Borax 3X HPUS

Collinsonia Canadensis 3X HPUS

Berberis Vulgaris 6X HPUS

Hamamelis Virginiana 6X HPUS

Inactive Ingredients

Allantoin, Benzalkonium Chloride 50%, Disodium EDTA, Glucono Delta Lactone, Polysorbate 20, Propanediol, Sodium Benzoate, Sodium Hydroxide, Tea Tree Oil, Water, Xanthan Gum


Structured Label Content

Indications and Usage (34067-9)

Uses For temporary relief of symptoms associate with vaginal yeast infection, including:itching, burning, and irritation.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medial help or contact a Poison Control Center right away. If in eyes, flush with water for 15 minutes and call a physician.

Section 50566-9 (50566-9)

Stop use and ask doctor if

  • Symptoms worsen, last more than 7 days, or clear up and occur again within a few days.
  • You get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
Section 50567-7 (50567-7)

When using this product

  • Wash hands thoroughly with soap and water before and after use
  • Avoid contact with eyes
  • If burning sensation occurs and lasts more than a few minutes, remove gel and discontinue use
  • Do not use more than one week unless directed by a doctor
  • If yoyu 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 serious condition.
  • Vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for you symptoms, including diabetes or a weakened immune system.
  • Been exposed to the human immunodeficiency virus (HIV) that causes AIDS
  • You have an STD (sexually transmitted disease) or PID (Pelvic inflammatory disease)
  • You have frequent and painful urination
Section 50570-1 (50570-1)

Do not use if

  • you have never had a vaginal yeast infection diagnosed by a doctor.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-800-635-3696

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose Temporary relief from external vagianl discomfort including itching, burning, and irritation

Warnings

For external vaginal use only. Use only as directed.

Directions

Directions

  • Apply to affected area as often as needed. Because the area is irritated, you could experience a slight burning sensation. If this persists more than a few minutes, remove gel and discontinue use.
  • Wash hand thoroughly with soap an dwater before and after use.
  • Do not use for children under two years. Consult a doctor if condition persists.
Other Information

Other information

  • Do not use if safety seal under cap is missing or broken
  • Store at room temperature
  • Lot number and expiration date: see date on tube and box flap.
  • Retain carton for complete Drug Facts Warnings
  • There is no scientific evidence that this product works. Ther product claims are based on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

Active Ingredients

Borax 3X HPUS

Collinsonia Canadensis 3X HPUS

Berberis Vulgaris 6X HPUS

Hamamelis Virginiana 6X HPUS

Inactive Ingredients

Allantoin, Benzalkonium Chloride 50%, Disodium EDTA, Glucono Delta Lactone, Polysorbate 20, Propanediol, Sodium Benzoate, Sodium Hydroxide, Tea Tree Oil, Water, Xanthan Gum


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)