FDA.reportPublic FDA data

The Pharma C Company Medicated Foam with Witch Hazel

Manufacturer
Kleen Test Products Corporation
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:40

Label at a glance#

ProductThe Pharma C Company Medicated Foam with Witch Hazel
Active ingredientWITCH HAZEL
Label structure8 sections

Indications and uses

temporarily relieves the local itching and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas  temporarily relieves irritation and burning

Dosage and administration

Adults:    when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry area by patting or blotting with toilet tissure or a soft cloth pump a small amount of foam onto clean toilet paper and apply externally to the affected area after application, flush toilet paper and wash hands medicated foam may be used up to 6 times daily or after each bowel movement Children under 12...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch hazel 50%

Purpose

OTC - PURPOSE SECTION

Hemorrhoidal astringent

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas 
  • temporarily relieves irritation and burning

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed unless told to do so by a doctor 
  • do not put directly in the rectum or vagina by using fingers or mechanical device

Stop use and ask doctor if

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults:   

  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry area by patting or blotting with toilet tissure or a soft cloth
  • pump a small amount of foam onto clean toilet paper and apply externally to the affected area
  • after application, flush toilet paper and wash hands
  • medicated foam may be used up to 6 times daily or after each bowel movement Children under 12 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Store at a controlled room temperature: 15-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, benzyl alcohol, citric acid, coco-glucoside, ethyl alcohol, glycerin, phenoxyethanol, potassium sorbate, propanediol, purified water, sodium citrate, tocopherol

Questions or comments?

OTC - QUESTIONS SECTION

1-844-308-8600

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2166922witch hazel 50 % Topical FoamPSN3
2166922witch hazel 500 MG/ML Topical FoamSCD3
2166922witch hazel 50 % Topical FoamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55239-358-00The Pharma C Company Medicated Foam with Witch Hazel210 mL in 1 BOTTLELIQUID2103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55239-358THE PHARMA C COMPANY MEDICATED FOAM WITH WITCH HAZEL (WITCH HAZEL) LIQUID [KLEEN TEST PRODUCTS CORPORATION]3Current NDC, Legacy NDC, 1 package rows20231110_1a1fbe83-be45-4654-a7bb-e934e1ccd0c6.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55239-35855239-358-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO GLUCOSIDEICS790225BIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
TOCOPHEROLR0ZB2556P8IACT
WITCH HAZEL101I4J0U34ACTIB

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
The Pharma C Company Medicated Foam with Witch HazelWITCH HAZELKleen Test Products Corporation1a1fbe83-be45-4654-a7bb-e934e1ccd0c62023-11-09WarningsExact identifier
ndc (package): 55239-358-00
ndc (product): 55239-358
ndc11 (package): 55239035800
spl id: 09c37c1c-308b-6d9f-e063-6394a90a5de3
spl set id: 1a1fbe83-be45-4654-a7bb-e934e1ccd0c6

Reported adverse events (FAERS/openFDA)#

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