SPL v1
SPL
SPL Set ID fb40241b-2239-4b82-806b-da152e1332c4
Route
TOPICAL
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Horse Chestnut (7 [hp_X]) Hamamelis Virginiana Leaf Water (2 [hp_X]) Paeonia Officinalis Whole Krameria Lappacea Root
Inactive Ingredients
Lanolin Glyceryl Monostearate Petrolatum Cetostearyl Alcohol Hydrogenated Castor Oil Glycerin Menthol, Unspecified Form Eucalyptus Oil Tea Tree Oil Linalool, (+)-

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-03-13

Description

Aesculus hippocastanum 7X HPUS (0.01 g)........................Reduces swelling and relieves stinging pain associated with external hemorrhoids                                                                                                            Hamamelis virginiana 2X HPUS (0.01 g)............................................Relieves burning, itching, and discomfort associated with hemorrhoids Paeonia officinalis (Peony) 2X H PUS (0.01 g)........................................Relieves burning pain and cozing associated with external hemorrhoids Ratanhia 7X HPUS (0.01 g)................................................................Relieves itching and discomfort from external hemorrhoids,                                                                                                          especially during and after bowel movements


Medication Information

Description

Aesculus hippocastanum 7X HPUS (0.01 g)........................Reduces swelling and relieves stinging pain associated with external hemorrhoids                                                                                                            Hamamelis virginiana 2X HPUS (0.01 g)............................................Relieves burning, itching, and discomfort associated with hemorrhoids Paeonia officinalis (Peony) 2X H PUS (0.01 g)........................................Relieves burning pain and cozing associated with external hemorrhoids Ratanhia 7X HPUS (0.01 g)................................................................Relieves itching and discomfort from external hemorrhoids,                                                                                                          especially during and after bowel movements

Uses

Temporarily Relives symptoms of hemorrhoids such as:

• Burning

• Itching

• Swelling

• Pain

• Discomfort

• Relives hemorrhoids symptoms

following childbirth

Section 50565-1

Section 55105-1

Warnings
  • For rectal use only.
  • Ask a doctor before usein case of bleeding.
  • When using this product, do not exceed the recommended daily dosage unless directed by a doctor.
  • Stop use and ask a doctor ifsymtoms persist for more than 7 days or worsen.
Directions

Step 1 - Cleanse: Thoroughly wash the affected area with mild soap and warm water. Pat dry gently with a clean, soft cloth.

Step 2 - Preparation: Open the Recral pre-filled applicator packaging and remove the applicator. Hold it upright with the cap on.

Step 3- Unscrew Cap: Unscrew the cap gently from the pre-filled applicator. Make sure not to squeeze the tube during this process.

Step 4- Positioning: Gently and carefully insert the rounded tip of the applicator into the rectum, following the natural curvature.

Step 5- Application: Squeeze the applicator gently to dispense the recommended dose of the treatment. Slowly withdraw the applicator

                              while continuing to apply the treatment.

Step 6 - Dispose: After use, discard the applicator and cap in a suitable waste bin. Do not flush the applicator down the toilet.

Step 7 - Hygiene: Cleanse your hands thoroughly with soap and water after use.

Product Label

Active Ingredient

Aesculus hippocastanum 7X HPUS (0.01 g)........................Reduces swelling and relieves stinging pain associated with external hemorrhoids                                                                                                           

Hamamelis virginiana 2X HPUS (0.01 g)............................................Relieves burning, itching, and discomfort associated with hemorrhoids

Paeonia officinalis (Peony) 2X H PUS (0.01 g)........................................Relieves burning pain and cozing associated with external hemorrhoids

Ratanhia 7X HPUS (0.01 g)................................................................Relieves itching and discomfort from external hemorrhoids,

                                                                                                         especially during and after bowel movements

Other Information 

If you experience any discomfort, irritation, or adverse reactions during or after use, discontinue use and consult a healthcare professional. Do not use if tamper-evident seal is broken or missing. Keep out of reach of children.

Inactive Ingredients

Lanolin, Glyceryl Stearate, Petrolatum, Cetearyl Alcohol, Hydrogenated Castor Oil, Glycerin, Menthol, Eucalyptus Globulus (Eucalyptus) Oil, Tea Tree Oil, Linalool


Structured Label Content

Uses

Temporarily Relives symptoms of hemorrhoids such as:

• Burning

• Itching

• Swelling

• Pain

• Discomfort

• Relives hemorrhoids symptoms

following childbirth

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings
  • For rectal use only.
  • Ask a doctor before usein case of bleeding.
  • When using this product, do not exceed the recommended daily dosage unless directed by a doctor.
  • Stop use and ask a doctor ifsymtoms persist for more than 7 days or worsen.
Directions

Step 1 - Cleanse: Thoroughly wash the affected area with mild soap and warm water. Pat dry gently with a clean, soft cloth.

Step 2 - Preparation: Open the Recral pre-filled applicator packaging and remove the applicator. Hold it upright with the cap on.

Step 3- Unscrew Cap: Unscrew the cap gently from the pre-filled applicator. Make sure not to squeeze the tube during this process.

Step 4- Positioning: Gently and carefully insert the rounded tip of the applicator into the rectum, following the natural curvature.

Step 5- Application: Squeeze the applicator gently to dispense the recommended dose of the treatment. Slowly withdraw the applicator

                              while continuing to apply the treatment.

Step 6 - Dispose: After use, discard the applicator and cap in a suitable waste bin. Do not flush the applicator down the toilet.

Step 7 - Hygiene: Cleanse your hands thoroughly with soap and water after use.

Product Label (Product label)

Active Ingredient

Aesculus hippocastanum 7X HPUS (0.01 g)........................Reduces swelling and relieves stinging pain associated with external hemorrhoids                                                                                                           

Hamamelis virginiana 2X HPUS (0.01 g)............................................Relieves burning, itching, and discomfort associated with hemorrhoids

Paeonia officinalis (Peony) 2X H PUS (0.01 g)........................................Relieves burning pain and cozing associated with external hemorrhoids

Ratanhia 7X HPUS (0.01 g)................................................................Relieves itching and discomfort from external hemorrhoids,

                                                                                                         especially during and after bowel movements

Other Information 

If you experience any discomfort, irritation, or adverse reactions during or after use, discontinue use and consult a healthcare professional. Do not use if tamper-evident seal is broken or missing. Keep out of reach of children.

Inactive Ingredients (Inactive ingredients)

Lanolin, Glyceryl Stearate, Petrolatum, Cetearyl Alcohol, Hydrogenated Castor Oil, Glycerin, Menthol, Eucalyptus Globulus (Eucalyptus) Oil, Tea Tree Oil, Linalool


Advanced Ingredient Data


Raw Label Data

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