PROCURE CLAMAPLEX- zinc oxide 20.625, menthol 0.44, white petrolatum 66.335 ointment

ProCure ClamaPlex by

Drug Labeling and Warnings

ProCure ClamaPlex by is a Otc medication manufactured, distributed, or labeled by Twin Med LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 0.44%

White Petrolatum 66.335%

Zinc Oxide 20.625%

Purpose

Menthol 0.44%.........................................Analgesic

White Petrolatum 66.335%...............................Protectant

Zinc Oxide 20.625%............Astringent / Protectant

Uses

• gives temporary relief of local itching and discomfort in the perianal area
• temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
• temporarily protects irritated areas
• temporarily relieves burning
• provides temporary relief from skin irritations
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
• temporarily protects inflamed perianal skin
• temporarily relieves the symptoms of perianal skin irritation
• may provide a cooling sensation

Warnings

Warnings

For external use only

Allergy Alert: certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

When using this product

When using this product

• do not exceed the recommended daily dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask doctor if

Stop using and ask a doctor if

• condition worsens or does not improve in 7 days
• bleeding occurs, consult a doctor promptly

Keep out of reach of children

Keep out of reach of Children. In case of accidental ingestion, contact a physician or Poison Control Center right away.

Directions

Directions

• Adults: when practical cleanse the 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. Apply to affected area up to 6 times daily.
• Children under 12 years of age: consult a doctor

Inactive Ingredients

Inactive Ingredients: Calamine, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROCURE CLAMAPLEX 
zinc oxide 20.625, menthol 0.44, white petrolatum 66.335 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	66.335 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.625 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.44 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOL (UNII: 339NCG44TV)
THYMOL (UNII: 3J50XA376E)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)

Product Characteristics
Color	pink (Light Pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-044-04	113 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2025
2	NDC: 55681-044-14	144 in 1 CARTON	12/01/2025
2	NDC: 55681-044-05	5 g in 1 PACKET; 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	12/01/2025

Labeler - Twin Med LLC (009579330)