FDA.reportPublic FDA data

Thera Wise Natural Hemorrhoidal

Manufacturer
Derma Wise Skin Care Ltd.
Effective date
2026-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:31:49

Label at a glance#

ProductThera Wise Natural Hemorrhoidal
Active ingredientWitch Hazel
Label structure10 sections

Indications and uses

For the temporary relief of anorectal discomfort associated with hemorrhoids For the temporary relief of local itching associated with hemorrhoids

Dosage and administration

When first opening, tear away safety seal. Adult: When practical cleanse the affected area with mild soap and warm water and rinse thoroughly and / or pat and blot with appropriate cleansing pad. Gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product. FOR INTRARECTAL USE: Remove cover from applicator, attach applicator to the tube. Lubricate applicator well, then ...

Storage and handling

Store between 2° and 25° C (35° - 77° F) Do not use if seal is broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch Hazel 12%

Purpose

OTC - PURPOSE SECTION

Astringent / Anti-inflammatory

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of anorectal discomfort associated with hemorrhoids
  • For the temporary relief of local itching associated with hemorrhoids

Warnings

WARNINGS SECTION

For rectal and external use only

SPL UNCLASSIFIED SECTION

Allergy alert: contains Asteracea (daisy) plant material

OTC - DO NOT USE SECTION

Do not use this product with the applicator if the introduction of the applicator into the rectum causes additional pain.

Consult a doctor promptly.

Stop use and consult a doctor if:

OTC - STOP USE SECTION

  • Condition worsens or does not improve within 7 days
  • Bleeding occurs

OTC - WHEN USING SECTION

When using this product do not exceed the recommended daily dosage unless directed by your doctor.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • When first opening, tear away safety seal.
  • Adult: When practical cleanse the affected area with mild soap and warm water and rinse thoroughly and / or
  • pat and blot with appropriate cleansing pad.
  • Gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product.
  • FOR INTRARECTAL USE: Remove cover from applicator, attach applicator to the tube.
  • Lubricate applicator well, then gently insert applicator into the rectum.
  • Thoroughly cleanse applicator after each use and replace cover.
  • Apply to the affected area up to 6 times daily or after each bowel movement.
  • Children under 12 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store between 2° and 25° C (35° - 77° F)
  • Do not use if seal is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Extract1, Argan Kernel Oil, Butcher's Broom Extract, Cetearyl Olivate, Chamomile Flower Extract1, Citric Acid, Dehydroacetic Acid, Glycerin, Grape Seed Oil, Hydrogenated Olive Oil, Oat Beta Glucan, Olive Oil, Olive Oil Unsaponifiables Olive Squalane, Seabuckthorn Fruit Oil, Sclerotium Gum, Shea Butter, Sodium Anisate, Sodium Levulinate, Sorbitan Olivate, Sodium Steroyl Glutamate, Stearyl Alcohol, Sunflower Seed Oil, Tocopherols, Water

1 Certified Organic

Questions or Comments?

OTC - QUESTIONS SECTION

Call weekdays 9am to 5pm PST @ 1.888.488.1808

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natural Hemorrhoidal Ointment

12 % WITCH HAZEL
For the temporary relief of itching and
discomfort associated with hemorrhoids

THÉRA WISE®

WITH BUTCHER'S BROOM, WITCH HAZEL, CHAMOMILE
& ALOE LEAF EXTRACT, OAT PREBIOTIC,
GRAPE SEED, SEABUCKTHORN & ARGAN OIL

NEW WT 1OZ (28g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Box
PRINCIPAL DISPLAY PANEL - 28 g Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1804849witch hazel 12 % Rectal OintmentPSN5
1804849witch hazel 0.12 MG/MG Rectal OintmentSCD5
1804849witch hazel 12 % Rectal OintmentSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43347-158-01Thera Wise Natural Hemorrhoidal28 g in 1 TUBE, WITH APPLICATOROINTMENT285
43347-158-01Thera Wise Natural Hemorrhoidal1 in 1 BOXOINTMENT15

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43347-15843347-158-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Witch Hazel101I4J0U34ACTIB
Aloe Vera LeafZY81Z83H0XIACT
Ruscus Aculeatus RootZW12V95I1QIACT
Cetearyl Olivate58B69Q84JOIACT
Chamaemelum Nobile FlowerO2T154T6OGIACT
Citric Acid Monohydrate2968PHW8QPIACT
Dehydroacetic acid2KAG279R6RIACT
GlycerinPDC6A3C0OXIACT
Grape Seed Oil930MLC8XGGIACT
Hydrogenated Olive Oil53839415GIIACT
Olive Oil6UYK2W1W1EIACT
Olea Europaea (Olive) Oil UnsaponifiablesXO45V955LTIACT
SqualaneGW89575KF9IACT
Betasizofiran2X51AD1X3TIACT
Shea ButterK49155WL9YIACT
Sodium AnisateF9WFJ28MV9IACT
Sodium LevulinateVK44E1MQU8IACT
Sorbitan OlivateMDL271E3GRIACT
Sodium Stearoyl Glutamate65A9F4P024IACT
Stearyl Alcohol2KR89I4H1YIACT
Sunflower Oil3W1JG795YIIACT
TocopherolR0ZB2556P8IACT
Glucosyl Hesperidin432C95B6YEIACT
Water059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
Thera Wise Natural HemorrhoidalWITCH HAZELDerma Wise Skin Care Ltd.a29fb680-cfc8-4a7b-9970-563fa0e2bed62026-01-06WarningsExact identifier
ndc (package): 43347-158-01
ndc (product): 43347-158
ndc11 (package): 43347015801
spl id: b0575217-f40b-44cc-a38d-9bb99fa49d00
spl set id: a29fb680-cfc8-4a7b-9970-563fa0e2bed6

Reported adverse events (FAERS/openFDA)#

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