GEM Cool Fresh

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: GEM Cool Fresh
Generic name: ALUMINUM CHLOROHYDRATE
Manufacturer: Gem Products US LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4a956c8b-5a82-8e07-e063-6294a90aa36b
SPL ID: 4a956c8b-5a83-8e07-e063-6294a90aa36b
Version: 1
Effective date: 2026-02-11
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:23

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M019	openfda.application_number
brand name		GEM Cool Fresh	openfda.brand_name
generic name		ALUMINUM CHLOROHYDRATE	openfda.generic_name
manufacturer name		Gem Products US LLC	openfda.manufacturer_name
ndc	package	87190-0051-0	openfda.package_ndc
ndc	product	87190-0051	openfda.product_ndc
ndc11	package	87190005100	derived:openfda.package_ndc
spl id		4a956c8b-5a83-8e07-e063-6294a90aa36b	id
spl set id		4a956c8b-5a82-8e07-e063-6294a90aa36b	set_id
unii		HPN8MZW13M	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 FLAMMABLE. DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING. CAN CAUSE SERIOUS INJURY OR DEATH. WHEN USING THIS PRODUCT KEEP AWAY FROM FACE AND MOUTH TO AVOID BREATHING IT • AVOID SPRAYING IN EYES. CONTENTS UNDER PRESSURE. DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURE ABOVE 120°F/50°C OR IN ENCLOSED PLACES THAT COULD OVERHEAT. USE ONLY IN A WELL-VENTILATED AREA. DO NOT USE ON BROKEN SKIN STOP USE IF RASH OR IRRITATION OCCURS. ASK A DOCTOR BEFORE USE IF YOU HAVE KIDNEY DISEASE. KEEP OUT OF REACH OF CHILDREN IF SWALLOWED GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY. USE ONLY AS DIRECTED. INTENTIONAL MISUSE BY DELIBERATLY CONCERNTRATING AND INHALING THE CONTENTS CAN BE HARMFUL OR FATAL. FOR EXTERNAL USE ONLY

Reported adverse events (FAERS/openFDA)#

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