PRAMOXINE HYDROCHLORIDE ANORECTAL- pramoxine hydrochloride lotion

Pramoxine Hydrochloride Anorectal by

Drug Labeling and Warnings

Pramoxine Hydrochloride Anorectal by is a Otc medication manufactured, distributed, or labeled by Stratus Pharmaceuticals, Tarmac Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Pramoxine HCL 1% w/w

Purpose

Local Anesthetic

Use

• for the temporary relief of itching and discomfort in the perianal area.

Warnings

for external use only.

Do not

• exceed the recommended daily dosage unless directed by a Physician.

Do not

• put this product into rectum by using fingers or any applicator.

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

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

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.

Questions or comments?

Call us at: 1-800-442-7882

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Distributed by:
STRATUS
PHARMACEUTICALS INC
Miami, Florida 33186

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)

INGREDIENTS AND APPEARANCE

PRAMOXINE HYDROCHLORIDE ANORECTAL 
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-522
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
Glycerin (UNII: PDC6A3C0OX)
Light Mineral Oil (UNII: N6K5787QVP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
LANOLIN (UNII: 7EV65EAW6H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
Sorbic Acid (UNII: X045WJ989B)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58980-522-40	1 in 1 BOX	11/01/2025
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58980-522-80	1 in 1 BOX	11/01/2025
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M015	11/01/2025

Labeler - Stratus Pharmaceuticals (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
Tarmac Products		059890491	MANUFACTURE(58980-522)