FDA.reportPublic FDA data

Dr Talbots Cooling Perineal Pad

Manufacturer
Talbot's Pharmaceuticals family Products, LLC.
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:08

Label at a glance#

ProductDr Talbots Cooling Perineal Pad
Active ingredientWITCH HAZEL
Label structure11 sections

Indications and uses

Helps relieve pain and swelling from hemmorrhoids and children. Temperoray relief from irritation. Burning Discomfort

Label contents#

Full prescribing information#

WARNINGS FOR EXTERNAL USE ONLY

WARNINGS SECTION

For external use only:

  • Avoid contact with eye. If contact occurs, rinse thoroughly with water.
  • Do not exceed the recommended daily dosage unless directed by doctor.
  • Do not put this product in the rectum by using fingers or any mechanical device or applicator.

Warning SectionWarning Section

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

​

  • WITCH HAZEL 50% - ASTRINGENT

Active IngredientsActive Ingredients

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

  • Water
  • aloe barbadensis leaf juice
  • bioflavonoids
  • calendula officinalis flower extract
  • citric acid
  • decyl glucoside
  • glycerin
  • lactic acid
  • levulinic acid
  • mentha piperita (peppermint) oil
  • sodium cocoamphoacetate
  • potassium sorbate

Inactive IngredientInactive Ingredient

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contract a Poison Control CEnter right away.

Keep Out of ReachKeep Out of Reach

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • Rectal bleeding occurs.
  • Condition worsens or does not improves within 7 days. Stop Use SectionStop Use Section

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Store at room temerature
  • single use per wipe
  • close lid after every use to retain moisture
  • Not flushable

Other Safety InformationOther Safety Information

USES

OTC - PURPOSE SECTION

  • Helps relieve pain and swelling from hemmorrhoids and children.
  • Temperoray relief from irritation.
  • Burning
  • Discomfort

Purpose SectionPurpose Section

DOSAGE & ADMINISTRATION SECTION

  • Dosage and Admin Section jpgDosage and Admin Section jpgRemove one liner from the pack and reseal the lid.
  • Place the liner on top of mom pad.
  • We recommend a Dr Talbot's Rapid Relief Perineal Pad.
  • Remove and dispose of the liner each time you change your pad.
  • Top up that cooling feeling with a squirt of DR Talbot's Perineal Soothing Foam as required.

INDICATION & USAGE SECTION

INDICATIONS & USAGE SECTION

  • ASTRINGENT
  • HELPS RELIEVES PAIN & SWELLING FROM HEMORRHOIDS & CHILDBIRTH
  • TEMPORARY RELIEF FROM IRRITATION, BURNING, DISCOMFORT

Indication and Usage SectionIndication and Usage Section

INDICATION AND USAGE SECTION

RECENT MAJOR CHANGES SECTION

  • Helps relieve pain and swelling from hemorrhoids and childbirth.
  • temporary relief from Irritation, Burning, Discomfort.

Indication of Usage SectionIndication of Usage Section

COOLING PERINEAL PAD LINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • SOOTHING RELIEF

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
844379witch hazel 50 % Medicated PadPSN2
844379witch hazel 500 MG/ML Medicated PadSCD2
844379witch hazel 50 % Medicated PadSY2
844379witch hazel 50 % Medicated WipesSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70797-104-01Dr Talbots Cooling Perineal Pad120 g in 1 PACKAGELIQUID1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-104DR TALBOTS COOLING PERINEAL PAD (WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE) LIQUID [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]2Current NDC, 1 package rows20250316_242277e2-ff26-ad4e-e063-6394a90ab317.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70797-10470797-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WITCH HAZEL101I4J0U34ACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT

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
Dr Talbots Cooling Perineal PadWATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATETalbot's Pharmaceuticals family Products, LLC.242277e2-ff26-ad4e-e063-6394a90ab3172025-03-14WarningsExact identifier
ndc (package): 70797-104-01
ndc (product): 70797-104
ndc11 (package): 70797010401
spl id: 30502321-9e0b-f1e0-e063-6394a90a4ed2
spl set id: 242277e2-ff26-ad4e-e063-6394a90ab317

Reported adverse events (FAERS/openFDA)#

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