Hemorrhoid Gel

Hemorrhoid Gel
SPL v1
SPL
SPL Set ID d2016513-9b47-490d-9396-766db4cafecd
Route
TOPICAL
Published
Effective Date 2022-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Achillea Millefolium (4 [hp_X]) Hamamelis Virginiana Root Bark/stem Bark (6 [hp_X]) Ruscus Aculeatus Whole (12 [hp_X]) Aloe (30 [hp_C]) Paeonia Officinalis Root Strychnos Ignatii Seed Nitric Acid Strychnos Nux-vomica Seed Phosphorus Podophyllum Anemone Pulsatilla Krameria Lappacea Root Horse Chestnut Chelidonium Majus Sulfur
Inactive Ingredients
Carbomer 980 Alcohol Aloe Vera Whole Water Sodium Hydroxide Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-12

Description

ACTIVE INGREDIENTS - equal amounts of: Achillea Millefolium 4X, Aesculus Hippocastanum 4X, 30C, Hamamelis Virginiana 4X, Ruscus Aculeatus 4X, Aloe Socotrina 6X, Paeonia Officinalis 6X, Ignatia Amara 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphorus 12X, Podophyllum Peitatum 12X, Pulsatilla 12X, Ratanhia 12X, 30C, Chelidonium Majus 30C, Sulphur 30C


Medication Information

Warnings and Precautions

WARNINGS:

  • FOR TOPICAL USE ONLY.
  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Indications and Usage

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

Dosage and Administration

DIRECTIONS: Lubricate applicator with a small amount of gel before use. Apply to area 5 to 6 times daily, especially after a bowel movement.

Description

ACTIVE INGREDIENTS - equal amounts of: Achillea Millefolium 4X, Aesculus Hippocastanum 4X, 30C, Hamamelis Virginiana 4X, Ruscus Aculeatus 4X, Aloe Socotrina 6X, Paeonia Officinalis 6X, Ignatia Amara 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphorus 12X, Podophyllum Peitatum 12X, Pulsatilla 12X, Ratanhia 12X, 30C, Chelidonium Majus 30C, Sulphur 30C

Section 34093-5

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6

INACTIVE INGREDIENTS: Carbomer 980, Ethanol Alcohol, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxide, USP Glycerin

Section 51945-4

NDC:43406-0709-5

Hemorrhoid Gel

HOMEOPATHIC

 2 oz (56.7g)

Section 53413-1

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

Section 55106-9

ACTIVE INGREDIENTS - equal amounts of: Achillea Millefolium 4X, Aesculus Hippocastanum 4X, 30C, Hamamelis Virginiana 4X, Ruscus Aculeatus 4X, Aloe Socotrina 6X, Paeonia Officinalis 6X, Ignatia Amara 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphorus 12X, Podophyllum Peitatum 12X, Pulsatilla 12X, Ratanhia 12X, 30C, Chelidonium Majus 30C, Sulphur 30C


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

Dosage and Administration (34068-7)

DIRECTIONS: Lubricate applicator with a small amount of gel before use. Apply to area 5 to 6 times daily, especially after a bowel movement.

Warnings and Precautions (34071-1)

WARNINGS:

  • FOR TOPICAL USE ONLY.
  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Section 34093-5 (34093-5)

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Carbomer 980, Ethanol Alcohol, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxide, USP Glycerin

Section 51945-4 (51945-4)

NDC:43406-0709-5

Hemorrhoid Gel

HOMEOPATHIC

 2 oz (56.7g)

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1 (55105-1)

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS - equal amounts of: Achillea Millefolium 4X, Aesculus Hippocastanum 4X, 30C, Hamamelis Virginiana 4X, Ruscus Aculeatus 4X, Aloe Socotrina 6X, Paeonia Officinalis 6X, Ignatia Amara 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphorus 12X, Podophyllum Peitatum 12X, Pulsatilla 12X, Ratanhia 12X, 30C, Chelidonium Majus 30C, Sulphur 30C


Advanced Ingredient Data


Raw Label Data

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