FDA.reportPublic FDA data

Perineal Cooling Liners

Manufacturer
CVS Pharmacy
Effective date
2025-02-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:55:54

Label at a glance#

ProductPerineal Cooling Liners
Active ingredientWITCH HAZEL
Label structure8 sections

Indications and uses

Helps relieve pain and swelling from hemorrhoids and childbirth. Temporary relief from:  Irritation Burning Discomfort.

Dosage and administration

remove one pad liner from pouch and place on top of maxi pad. close lid after use to retain moisture. replace pad liner with each maxi pad change.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch hazel 50%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve pain and swelling from hemorrhoids and childbirth.
  • Temporary relief from: 
  • Irritation
  • Burning
  • Discomfort.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. if contact occurs, rinse thoroughly with water.
  • 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 a 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

  • remove one pad liner from pouch and place on top of maxi pad.
  • close lid after use to retain moisture.
  • replace pad liner with each maxi pad change.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature.
  • close lid after every use to retain moisture.
  • discard after every use.
  • not flushable.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol, sodium benzoate, phenoxyethanol, sodium lauroamphoacetate, benzalkonium chloride, glycerin, benzoic acid, citric acid, Mentha Piperita (Peppermint) Oil, menthyl lactate, sodium citrate, Chamomilla Recutita (Matricaria) Extract, tocopherol

Questions?

OTC - QUESTIONS SECTION

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51316-716-002025-02-25C16284748780-12cef2736-65dd-d83d-e063-dadaa90ab31fPerineal Cooling Liners
51316-716-002025-01-30C16284748780-12cef2736-65dd-d83d-e063-dadaa90ab31fPerineal Cooling Liners

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-716-00Perineal Cooling Liners24 in 1 BAGSWAB242
51316-716-00Perineal Cooling Liners1 in 1 BOXSWAB12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-716PERINEAL COOLING LINERS (WITCH HAZEL) SWAB [CVS PHARMACY]2Current NDC, Legacy NDC, 2 package rows20250226_88f44650-8fb7-4eb2-901d-30eb8415dc2b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-71651316-716-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
GLYCERINPDC6A3C0OXIACT
BENZOIC ACID8SKN0B0MIMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PEPPERMINT OILAV092KU4JHIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
SODIUM CITRATE1Q73Q2JULRIACT
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZIACT
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
Perineal Cooling LinersWITCH HAZELCVS Pharmacy88f44650-8fb7-4eb2-901d-30eb8415dc2b2025-02-25WarningsExact identifier
ndc (package): 51316-716-00
ndc (product): 51316-716
ndc11 (package): 51316071600
spl id: 2ef252e6-d890-86b2-e063-6294a90a45db
spl set id: 88f44650-8fb7-4eb2-901d-30eb8415dc2b

Reported adverse events (FAERS/openFDA)#

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