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

Purpose

Local Anesthetic

Description

Drug Facts


Medication Information

Warnings

for external use only.

Purpose

Local Anesthetic

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.
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.

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.

Active Ingredient

Pramoxine HCL 1% w/w

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

Warnings

for external use only.

Purpose

Local Anesthetic

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.
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.

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.

Active Ingredient (Active ingredient)

Pramoxine HCL 1% w/w

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

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