FDA.reportPublic FDA data

ProCure ClamaPlex

Manufacturer
Twin Med LLC
Effective date
2025-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:18:45

Label at a glance#

ProductProCure ClamaPlex
Active ingredientWHITE PETROLATUM, ZINC OXIDE, MENTHOL
Label structure7 sections

Indications and 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 inflam...

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44%

White Petrolatum 66.335%

Zinc Oxide 20.625%

Purpose

OTC - PURPOSE SECTION

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

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

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

Uses

INDICATIONS & USAGE SECTION

  • 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 SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CalmaPlex ImageCalmaPlex Image

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10840330701195GTIN-14: 10840330701195
GTIN storage (14 digits): 10840330701195		CalmaPlex Image.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-044-04ProCure ClamaPlex113 g in 1 TUBEOINTMENT1131
55681-044-05ProCure ClamaPlex5 g in 1 PACKETOINTMENT51
55681-044-14ProCure ClamaPlex144 in 1 CARTONOINTMENT1441

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-04455681-044-04, 55681-044-05, 55681-044-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE PETROLATUMB6E5W8RQJ4ACTIB
PHENOL339NCG44TVIACT
THYMOL3J50XA376EIACT
MINERAL OILT5L8T28FGPIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ZINC OXIDESOI2LOH54ZACTIB
FERRIC OXIDE RED1K09F3G675IACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure ClamaPlexZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335Twin Med LLC3d366857-5178-9032-e063-6294a90a40f32025-11-01WarningsExact identifier
ndc (package): 55681-044-14
ndc (package): 55681-044-04
ndc (package): 55681-044-05
ndc (product): 55681-044
ndc11 (package): 55681004404
ndc11 (package): 55681004414
ndc11 (package): 55681004405
spl id: 3d366857-5179-9032-e063-6294a90a40f3
spl set id: 3d366857-5178-9032-e063-6294a90a40f3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.