Cool Comfort

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Cool Comfort
Generic name: ORGANIC WITCH HAZEL
Manufacturer: Naticura Inc
Product type: HUMAN OTC DRUG
SPL set ID: de14c19c-56b5-4727-9194-94e85425ca8a
SPL ID: 453a56c6-c855-bf95-e063-6394a90ac750
Version: 6
Effective date: 2025-12-05
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:05:25

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Cool Comfort	openfda.brand_name
generic name		ORGANIC WITCH HAZEL	openfda.generic_name
manufacturer name		Naticura Inc	openfda.manufacturer_name
ndc	package	71453-211-00	openfda.package_ndc
ndc	product	71453-211	openfda.product_ndc
ndc11	package	71453021100	derived:openfda.package_ndc
rxcui		1990878	openfda.rxcui
spl id		453a56c6-c855-bf95-e063-6394a90ac750	id
spl set id		de14c19c-56b5-4727-9194-94e85425ca8a	set_id
unii		101I4J0U34	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.(1-800-222-1222) When using this product 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 0 C)

Reported adverse events (FAERS/openFDA)#

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