Pramoxine Hydrochloride 1% Anorectal Lotion

Pramoxine Hydrochloride 1% Anorectal Lotion
SPL v1
SPL
SPL Set ID 39a16b66-b0e9-412f-8773-8dec0a1227e0
Route
TOPICAL
Published
Effective Date 2025-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetyl Palmitate Glycerin Light Mineral Oil White Petrolatum Stearic Acid Trolamine Peg-40 Monostearate Stearyl Alcohol Lanolin Potassium Sorbate Diisopropyl Adipate Sorbic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Drug Facts

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Drug Facts

Use
  • for the temporary relief of itching and discomfort in the perianal area.
Do Not
  • exceed the recommended daily dosage unless directed by a Physician.
Section 42229-5

Drug Facts

Section 50565-1

Keep this product out of the reach of children. If swallowed, get medical attention or contact a Poison Control Center right away.

Warnings

for external use only.

Directions
  • Shake well before using.
  • When practical, cleansethe affected area with mild soap and warm water and rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Adults and children 12 years of age and older: apply to affected area up to five times daily.
  • Children under 12 years of age, consult a Physician.
Active Ingredient

Pramoxine HCL 1% w/w

Inactive Ingredients

Carbomer 940, Cetyl Alcohol, Di-isopropyl Adipate, Dimethicone, Glycerin 99.7%, Lanolin Anhydrous, Light Mineral Oil, PEG 40 Stearate, Potassium Sorbate, Purified Water, Sorbic Acid, Stearic Acid, Stearyl Alcohol, Trolamine, Ultimate White Petrolatum.

Questions Or Comments?

Call us at: 1-800-442-7882

Stop Use and Ask A Physician If
  • Condition worsens
  • Symptoms do not improve in 7 days
  • Allergic reactions develop to ingredients in this product
  • Symptoms being treated do not improve or subsideor if redness, irritation, swelling, pain, bleeding or other symptoms develop or increase
Principal Display Panel 118 Ml Bottle Box

NDC 58980-522-40

ANORECTAL

PRAMOXINE

HYDROCHLORIDE 1%

ANORECTAL

FAST RELIEF FROM ITCH

AND DISCOMFORT

ANORECTAL

(hemorrhoidal)

LOTION

Net 4 fl oz (118 mL)


Structured Label Content

Use
  • for the temporary relief of itching and discomfort in the perianal area.
Do Not (Do not)
  • exceed the recommended daily dosage unless directed by a Physician.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep this product out of the reach of children. If swallowed, get medical attention or contact a Poison Control Center right away.

Purpose

Local Anesthetic

Warnings

for external use only.

Directions
  • Shake well before using.
  • When practical, cleansethe affected area with mild soap and warm water and rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Adults and children 12 years of age and older: apply to affected area up to five times daily.
  • Children under 12 years of age, consult a Physician.
Active Ingredient (Active ingredient)

Pramoxine HCL 1% w/w

Inactive Ingredients (Inactive ingredients)

Carbomer 940, Cetyl Alcohol, Di-isopropyl Adipate, Dimethicone, Glycerin 99.7%, Lanolin Anhydrous, Light Mineral Oil, PEG 40 Stearate, Potassium Sorbate, Purified Water, Sorbic Acid, Stearic Acid, Stearyl Alcohol, Trolamine, Ultimate White Petrolatum.

Questions Or Comments? (Questions or comments?)

Call us at: 1-800-442-7882

Stop Use and Ask A Physician If (Stop use and ask a Physician if)
  • Condition worsens
  • Symptoms do not improve in 7 days
  • Allergic reactions develop to ingredients in this product
  • Symptoms being treated do not improve or subsideor if redness, irritation, swelling, pain, bleeding or other symptoms develop or increase
Principal Display Panel 118 Ml Bottle Box (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Box)

NDC 58980-522-40

ANORECTAL

PRAMOXINE

HYDROCHLORIDE 1%

ANORECTAL

FAST RELIEF FROM ITCH

AND DISCOMFORT

ANORECTAL

(hemorrhoidal)

LOTION

Net 4 fl oz (118 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)