SPL v1
SPL
SPL Set ID 2fb02b00-acdb-5184-e063-6294a90ae1c8
Route
TOPICAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (15 g) Lidocaine (5 g) Glycerin (14.4 g) Phenylephrine (0.25 g)
Inactive Ingredients
Edetate Disodium Mineral Oil Bha Water Citric Acid Phenoxyethanol Stearyl Alcohol Cellulose Gum Aloe Barbadensis Leaf Ethylhexylglycerin Glyceryl Stearate Propylene Glycol Propyl Gallate Sorbitan Olivate Steareth-21 Tocopherol Cetyl Alcohol Alpha-tocopherol Acetate Xanthan Gum Panthenol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Active Ingredients Glycerin 14.4% Lidocaine 5% Petrolatum 15% Phenylephrine HCL 0.25%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • for the temporary reliedf of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for the relief of anorectal discomforts
  • temporarily protects the inflamedm irritated abirectak syrface to help make bowel movements less painful

Dosage and Administration

Directions

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

Active Ingredients Glycerin 14.4% Lidocaine 5% Petrolatum 15% Phenylephrine HCL 0.25%

Section 42229-5

Made in USA With Globally Sourced Ingedients

NDC 72559-037-08

REV 037-08-01

Distributed by: Little Pharma, Inc.

New York, NY 10023

Section 44425-7

Other information

store at 15° - 30°C (59°-86°F)

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not imporve within seven (7) days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or thor symptons develop or increase
Section 50567-7

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put his product into rectum by using fingers or any mechanical device or applicator
Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficult in urination due to the enlargement of the prostate gland
Section 51727-6

Inactive Ingredients

aloe barbadensis leaf extract, BHA, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, mineral oil, panthenol, phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, zanthan gum

Section 51945-4

curist

Hemorrhoid & Fissure Relief

Glycerin 14.%

Lidocaine 5%

Petrolatum 15%

Phenylephrine HCL 0.25%

Hemorrhoidal Cream

Provides a Soothing Protective Layer

Temporary Relief of Pain,

Itching, adn Burning

Reduces Swelling

Net Wt. 6 oz (170g)

Section 53413-1

Questions? Call 1-844-243-1241 or email [email protected]

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose

Hemorrhoidal Cream

Section 55106-9

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Petrolatum 15%

Phenylephrine HCL 0.25%

Section 60561-8

If swallowed, get medical help or contact a Poison Control Center right sway (1-800-222-1222)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary reliedf of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for the relief of anorectal discomforts
  • temporarily protects the inflamedm irritated abirectak syrface to help make bowel movements less painful

Dosage and Administration (34068-7)

Directions

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

Warnings

For external use only

Section 42229-5 (42229-5)

Made in USA With Globally Sourced Ingedients

NDC 72559-037-08

REV 037-08-01

Distributed by: Little Pharma, Inc.

New York, NY 10023

Section 44425-7 (44425-7)

Other information

store at 15° - 30°C (59°-86°F)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not imporve within seven (7) days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or thor symptons develop or increase
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put his product into rectum by using fingers or any mechanical device or applicator
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficult in urination due to the enlargement of the prostate gland
Section 51727-6 (51727-6)

Inactive Ingredients

aloe barbadensis leaf extract, BHA, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, mineral oil, panthenol, phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, zanthan gum

Section 51945-4 (51945-4)

curist

Hemorrhoid & Fissure Relief

Glycerin 14.%

Lidocaine 5%

Petrolatum 15%

Phenylephrine HCL 0.25%

Hemorrhoidal Cream

Provides a Soothing Protective Layer

Temporary Relief of Pain,

Itching, adn Burning

Reduces Swelling

Net Wt. 6 oz (170g)

Section 53413-1 (53413-1)

Questions? Call 1-844-243-1241 or email [email protected]

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Hemorrhoidal Cream

Section 55106-9 (55106-9)

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Petrolatum 15%

Phenylephrine HCL 0.25%

Section 60561-8 (60561-8)

If swallowed, get medical help or contact a Poison Control Center right sway (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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