Astonea Hemorrhoidal Cream

Astonea Hemorrhoidal Cream
SPL v4
SPL
SPL Set ID e9c32d81-cd9d-4ff2-e053-2995a90aa499
Route
TOPICAL
Published
Effective Date 2021-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (14 g) Phenylephrine (0.25 g) Petrolatum (74.9 g)
Inactive Ingredients
Polyoxyl 100 Stearate Propylene Glycol White Wax Thymus Vulgaris Leaf Benzoic Acid .alpha.-tocopherol Acetate Butylated Hydroxyanisole Corn Oil Glycerin Lanolin Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-05

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
  • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
Dosage and Administration

Directions

  • Adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
  • To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly
  • Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement
  • Children under 12 years of age: ask a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

store at 20-25°C (68-77°F)

Section 50565-1

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

Section 50568-5

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

Section 51727-6

Inactive ingredients

Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, PEG-40 Hydrogenated Castor Oil, PEG-100 Stearate, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Mineral Oil (14% w/w)............................................. Skin Protectant

Petrolatum (74.9% w/w)........................................... Skin Protectant



Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor

Principal Display Panel

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
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

Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
  • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
Dosage and Administration (34068-7)

Directions

  • Adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
  • To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly
  • Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement
  • Children under 12 years of age: ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

store at 20-25°C (68-77°F)

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

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

Section 51727-6 (51727-6)

Inactive ingredients

Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, PEG-40 Hydrogenated Castor Oil, PEG-100 Stearate, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Mineral Oil (14% w/w)............................................. Skin Protectant

Petrolatum (74.9% w/w)........................................... Skin Protectant



Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

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