Bunnies Bum Creme Soothing Hemorrhoidal

Bunnies Bum Creme Soothing Hemorrhoidal
SPL v1
SPL
SPL Set ID 1c81582c-7ece-182f-e063-6294a90a8fbc
Route
TOPICAL
Published
Effective Date 2024-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (14.4 g) Petrolatum (15 g) Phenylephrine (0.25 g) Lidocaine (5 g)
Inactive Ingredients
Citric Acid Monohydrate Propyl Gallate Edetate Disodium Mineral Oil Anhydrous Dextrose Glyceryl Monostearate Butylated Hydroxytoluene Panthenol Stearyl Alcohol Carboxymethylcellulose Sodium Tocopherol Cetyl Alcohol Phenoxyethanol Aloe Vera Leaf Ascorbic Acid Indian Frankincense .alpha.-tocopherol Acetate Turmeric Propylene Glycol Asian Ginseng Sorbitan Olivate Steareth-21 Water Ethylhexylglycerin Xanthan Gum Bromelains Salix Alba Bark

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-08

Description

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


Medication Information

Warnings and Precautions

For external use only.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
Indications and Usage
  • For the temporary relief of pain, soreness, and burning
  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily provides a costing for the relief of anorectal discomforts
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and Administration
  • Adults: when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times a day, especially at night, in the morning, or after each bowel movement.
  • Children under 12 years of age: consult a doctor.
Description

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aloe barbadensis leaf extract, ascorbic acid, BHT, boswellia serrata extract, bromelain, cellulose gum, cetyl alcohol, citric acid, curcuma long (turmeric) root extract, disodium EDTA, ethylhexylglycerin, glucose, glyceryl stearate, mineral oil, panax ginseng root extract, panthenol, phenoxyethanol, propyl gallate, propylene glycol, salix alba (willow) bark extract, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Glycerin-Protectant

Lidocaine-Local anesthetic

Petrolatum-Protectant

Phenylephrine HCl Vasoconstrictor

Section 55106-9

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


Structured Label Content

Indications and Usage (34067-9)
  • For the temporary relief of pain, soreness, and burning
  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily provides a costing for the relief of anorectal discomforts
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and Administration (34068-7)
  • Adults: when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times a day, especially at night, in the morning, or after each bowel movement.
  • Children under 12 years of age: consult a doctor.
Warnings and Precautions (34071-1)

For external use only.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aloe barbadensis leaf extract, ascorbic acid, BHT, boswellia serrata extract, bromelain, cellulose gum, cetyl alcohol, citric acid, curcuma long (turmeric) root extract, disodium EDTA, ethylhexylglycerin, glucose, glyceryl stearate, mineral oil, panax ginseng root extract, panthenol, phenoxyethanol, propyl gallate, propylene glycol, salix alba (willow) bark extract, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Glycerin-Protectant

Lidocaine-Local anesthetic

Petrolatum-Protectant

Phenylephrine HCl Vasoconstrictor

Section 55106-9 (55106-9)

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


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