Cool Comfort

Manufacturer
Naticura Inc | PREMIER CARE INDUSTRIES, INC
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:20:28

Label at a glance#

ProductCool Comfort
Active ingredientWITCH HAZEL
Label structure7 sections

Indications and uses

helps relieve the local itching and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas. temporary relieves burning and irritation.

Dosage and administration

adult: cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area. use up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discard Dispose of pad in trash after use.Do not flush children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Organic Witch hazel 60%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas.
  • temporary relieves burning and irritation.

Warnings

WARNINGS SECTION

For external use only.

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.(1-800-222-1222)

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 into rectum by using fingers or any mechanical device or applicator
  • Store at room temperature 59-86 o​F (15-30 0C)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adult: cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
  • use up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discard
  • Dispose of pad in trash after use.Do not flush
  • children under 12 years of age: consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Organic Aloe Vera gel, Organic Glycerin, Natural Grain Alcohol, Organic Jojoba, Organic essential oils of Lavender, Cypress, Geranium.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71453-211-00

Naticura

CoolComfort

Personal Medicated Cleanisng Pads

Cools, Soothes, Comforts

Hemorrhoidal Pads with Organic Witch Hazel and Aloe

Organic non-GMO Ingredients for your safety: Paraben Free and Chemical Free

100 Moist Soft Cloth Pads

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1990878witch hazel 60 % Medicated PadPSN6
1990878witch hazel 600 MG/ML Medicated PadSCD6
1990878witch hazel 60 % Medicated PadSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X001DZY4EP100.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71453-211-00Cool Comfort100 in 1 PACKAGESWAB1006
71453-211-00Cool Comfort2.9 g in 1 PACKETSWAB2.96

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71453-21171453-211-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
Cool ComfortORGANIC WITCH HAZELNaticura Incde14c19c-56b5-4727-9194-94e85425ca8a2025-12-05WarningsExact identifier
ndc (package): 71453-211-00
ndc (product): 71453-211
ndc11 (package): 71453021100
spl id: 453a56c6-c855-bf95-e063-6394a90ac750
spl set id: de14c19c-56b5-4727-9194-94e85425ca8a

Reported adverse events (FAERS/openFDA)#

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