SPL v2
SPL
SPL Set ID d3fa14b2-3679-4549-b29a-5ab90c4c12d2
Route
TOPICAL
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (144 mg) Lidocaine (50 mg) Petrolatum (150 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Aloe Vera Leaf Carboxymethylcellulose Sodium, Unspecified Cetyl Alcohol Citric Acid Monohydrate Edetate Disodium Glyceryl Stearate Se Methylparaben Mineral Oil Panthenol Propyl Gallate Propylene Glycol Sodium Benzoate Steareth-2 Steareth-21 Stearyl Alcohol Tocopherol .alpha.-tocopherol Acetate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-15

Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Purpose

Protectant Local anesthetic Vasoconstrictor Protectant


Medication Information

Purpose

Protectant Local anesthetic Vasoconstrictor Protectant

Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Uses
  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
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 53414-9

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

Warnings

Purpose 

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Drug Fact 

Directions 
  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor
Other Information 

Store at controlled room temperature 20-25°C (68-77°F)

Active Ingredients 

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Inactive Ingredients 

 Aloe Barbadensis Leaf, Cellulose Gum, Cetyl Alcohol, Citric Acid , Citric Acid Anhydrous, Disodium EDTA, Glyceryl Stearate SE, Methylparaben, Mineral Oil, Panthenol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Steareth-2, Steareth-21, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Water (purified), Xanthan Gum

Principal Display Panel 

Target up & up            NDC 82442-030-28

Rapid Relief 

Hemorroidal Cream 

NET WT 1 OZ (28g)

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

Uses
  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
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 53414-9 (53414-9)

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

Warnings

Purpose 

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Drug Fact 

Directions 
  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor
Other Information  (Other information )

Store at controlled room temperature 20-25°C (68-77°F)

Active Ingredients  (Active ingredients )

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Inactive Ingredients  (Inactive ingredients )

 Aloe Barbadensis Leaf, Cellulose Gum, Cetyl Alcohol, Citric Acid , Citric Acid Anhydrous, Disodium EDTA, Glyceryl Stearate SE, Methylparaben, Mineral Oil, Panthenol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Steareth-2, Steareth-21, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Water (purified), Xanthan Gum

Principal Display Panel 

Target up & up            NDC 82442-030-28

Rapid Relief 

Hemorroidal Cream 

NET WT 1 OZ (28g)

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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