SPL v2
SPL
SPL Set ID 0dfe58cd-713c-4a0d-88e2-1604fe13292a
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]) Berberis Vulgaris Root Bark (3 [hp_X]) Borate Ion Collinsonia Canadensis Root
Inactive Ingredients
Sodium Benzoate Sodium Lauryl Sulfate Bacillus Coagulans Edetic Acid Maltodextrin Citric Acid Monohydrate Water Sodium Phosphate, Tribasic, Anhydrous

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-10-01

Description

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


Medication Information

Description

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

Uses

Uses For the temporary relief of symptoms associated with vagianl yeast infection, including:

  • itching
  • burning
  • irritation
Section 50566-9

Stop use and ask a doctor if:

  • Symptoms last more than 7 days
  • You get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vagina.
Section 50567-7

When using this product

  • 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 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 commetns? 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 vaginal itching, burning and irritation

Section 60561-8

Other information

  • a douche is not a contraceptive and should not be used to prevent pregnancy
  • do not use if foil seal on bottle opening is missing, torn damaged in any way. use if homeopathic packet is torn, open or incompletely sealed. purchase if carton is open
  • Store at room temperature
  • Lot number and expiration date: see upper back panel of box
  • 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.

Warnings
  • Use only as directed
  • For vaginal use only

Directions

Directions

Tamper Evident: If the foil seal on bottle opening is missing, torn or damaged in any way, do not use.

  • Wash hands thoroughly with soap and water before and after use
  • remove cap and safety seal from bottle. Carefully open teh packet and pour homeopathic contents into the douche bottle. Screw cap back onto bottle and shake thoroughly to fully mix powder into solution. After fully mixed, remove cap. Remove sanitary wrap from nozzle. Screw nozzle onto douche bottle.
  • Slowly insert nozzle into vagina about 3 inches. If needed, a small amount of personal lubricant can be applied to nozzle to ease insertion of nozzle into vagina. Gently squeeze bottle until solution is dispensed. Use while sittion on the toilet, standing in the shower or in the tub. After douching discard bottle and nozzle.

Active Ingredients

Borax 3X HPUS

Collinsonia Canadensis 3X HPUS

Berberis Vulgaris 6X HPUS

Hamamelis Virginiana 6X HPUS

Inactive Ingredients

Bacillus coagulans, citric acid, edetate disodium, maltodextrin, purified water, sodium benzoate, sodium lauryl sulfate, trisodium phosphate

Keep Out of Reach of Children.

Keep out of reach of children. If swallowed, get medial help or contact a Poison Control Center right away


Structured Label Content

Uses

Uses For the temporary relief of symptoms associated with vagianl yeast infection, including:

  • itching
  • burning
  • irritation
Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • Symptoms last more than 7 days
  • You get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vagina.
Section 50567-7 (50567-7)

When using this product

  • 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 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 commetns? 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 vaginal itching, burning and irritation

Section 60561-8 (60561-8)

Other information

  • a douche is not a contraceptive and should not be used to prevent pregnancy
  • do not use if foil seal on bottle opening is missing, torn damaged in any way. use if homeopathic packet is torn, open or incompletely sealed. purchase if carton is open
  • Store at room temperature
  • Lot number and expiration date: see upper back panel of box
  • 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.

Warnings
  • Use only as directed
  • For vaginal use only

Directions

Directions

Tamper Evident: If the foil seal on bottle opening is missing, torn or damaged in any way, do not use.

  • Wash hands thoroughly with soap and water before and after use
  • remove cap and safety seal from bottle. Carefully open teh packet and pour homeopathic contents into the douche bottle. Screw cap back onto bottle and shake thoroughly to fully mix powder into solution. After fully mixed, remove cap. Remove sanitary wrap from nozzle. Screw nozzle onto douche bottle.
  • Slowly insert nozzle into vagina about 3 inches. If needed, a small amount of personal lubricant can be applied to nozzle to ease insertion of nozzle into vagina. Gently squeeze bottle until solution is dispensed. Use while sittion on the toilet, standing in the shower or in the tub. After douching discard bottle and nozzle.

Active Ingredients

Borax 3X HPUS

Collinsonia Canadensis 3X HPUS

Berberis Vulgaris 6X HPUS

Hamamelis Virginiana 6X HPUS

Inactive Ingredients (Inactive ingredients)

Bacillus coagulans, citric acid, edetate disodium, maltodextrin, purified water, sodium benzoate, sodium lauryl sulfate, trisodium phosphate

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children. If swallowed, get medial help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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