SPL v2
SPL
SPL Set ID 8335e5ca-a2eb-d27a-e053-2a91aa0a7dc3
Route
TOPICAL
Published
Effective Date 2019-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Equisetum Arvense Top (3 [hp_X]) Salix Alba Bark Stellaria Media Urtica Urens Horse Chestnut Comfrey Root Daphne Mezereum Bark Althaea Officinalis Root Hamamelis Virginiana Root Bark/stem Bark Calendula Officinalis Flowering Top
Inactive Ingredients
Aloe Vera Leaf Adansonia Digitata Seed Oil Citric Acid Monohydrate Methyl Glucose Dioleate Carboxypolymethylene Potassium Sorbate Water Sodium Hydroxide Caprylyl Glycol Clove Oil Silver Citrate Hyaluronic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-03-18

Description

All active ingredients are HPUS* in equal proportion at 2x potency Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off. Salix Alba, Stellaria Med. Mezereum Off., Urtica Urens Althaea Off., Hamamelis Vir. *HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • Helps reduce potential infection in minor cuts, scrapes, and abrasions.
  • For temporary relief of itchiness and soreness.
  • Promotes wound healing.

Indications are based on Materia Medica, not clinical tests.

Dosage and Administration
  • clean the affected area
  • apply a small amount of this product on the area 2 to 3 times daily
  • may be covered with a steril bandage
Description

All active ingredients are HPUS* in equal proportion at 2x potency Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off. Salix Alba, Stellaria Med. Mezereum Off., Urtica Urens Althaea Off., Hamamelis Vir. *HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Section 44425-7
  • Store in a cool, dry place
  • Avoid direct sunlight
  • Tamper-evident for your protection. Use only if safety seal is intact.
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poisin Control Center right away.

Section 50566-9

Stop use and ask doctor if:

  • condition worsens or lasts more than 1 week
  • symptoms clear up and reoccur within a few days
Section 50570-1

Do not use if you have:

  • deep or puncture wounds
  • animal bites
  • serious burns
  • rash develops

-----

Do not use:

  • over large areas of the body
  • in eyes
Section 51727-6

Colloidal Silver Citrate, Purified Water, Caprylyl Glycol, Aloe Vera Barbadensis (BiAloe), Methyl Glucose Dioleate, Carbomer, Sodium Hydroxide, Baobab Oil, Clove Oil, Potassium Sorbate, Citric Acid, Hyaluronic Acid

Section 51945-4

Section 53413-1

1-888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

Section 55105-1

All active ingredients are HPUS* in equal proportion at 2x potency

Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off. ................................Promotes Wound Healing

Salix Alba, Stellaria Med. ......................................Topical Analgesic

Mezereum Off., Urtica Urens ................................ Reduces Itching

Althaea Off., Hamamelis Vir. .................................Anti-inflammatory

*HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Section 55106-9

All active ingredients are HPUS* in equal proportion at 2x potency

Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off.

Salix Alba, Stellaria Med.

Mezereum Off., Urtica Urens

Althaea Off., Hamamelis Vir.

*HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.


Structured Label Content

Indications and Usage (34067-9)
  • Helps reduce potential infection in minor cuts, scrapes, and abrasions.
  • For temporary relief of itchiness and soreness.
  • Promotes wound healing.

Indications are based on Materia Medica, not clinical tests.

Dosage and Administration (34068-7)
  • clean the affected area
  • apply a small amount of this product on the area 2 to 3 times daily
  • may be covered with a steril bandage
Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)
  • Store in a cool, dry place
  • Avoid direct sunlight
  • Tamper-evident for your protection. Use only if safety seal is intact.
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poisin Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if:

  • condition worsens or lasts more than 1 week
  • symptoms clear up and reoccur within a few days
Section 50570-1 (50570-1)

Do not use if you have:

  • deep or puncture wounds
  • animal bites
  • serious burns
  • rash develops

-----

Do not use:

  • over large areas of the body
  • in eyes
Section 51727-6 (51727-6)

Colloidal Silver Citrate, Purified Water, Caprylyl Glycol, Aloe Vera Barbadensis (BiAloe), Methyl Glucose Dioleate, Carbomer, Sodium Hydroxide, Baobab Oil, Clove Oil, Potassium Sorbate, Citric Acid, Hyaluronic Acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

Section 55105-1 (55105-1)

All active ingredients are HPUS* in equal proportion at 2x potency

Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off. ................................Promotes Wound Healing

Salix Alba, Stellaria Med. ......................................Topical Analgesic

Mezereum Off., Urtica Urens ................................ Reduces Itching

Althaea Off., Hamamelis Vir. .................................Anti-inflammatory

*HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Section 55106-9 (55106-9)

All active ingredients are HPUS* in equal proportion at 2x potency

Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off.

Salix Alba, Stellaria Med.

Mezereum Off., Urtica Urens

Althaea Off., Hamamelis Vir.

*HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.


Advanced Ingredient Data


Raw Label Data

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