FULL EIGHT - COOLING GEL (82551-119)

Manufacturer: FULL EIGHT Inc
Effective date: 2024-10-11
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: full-release
Hydrated at: 2026-06-01 00:25:25

Label at a glance#

ProductCOOLING

Active ingredientMENTHOL

Label structure9 sections

Dosage and administration

Adults 18 years of age and older: Massage into skin at affected areas before bed & when symptoms arise

Contacts and useful links#

PhoneLabel contact704-461-3009

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 1.2%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USE

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pain such as cramps, sore muscles, arthritis, muscle strains, and bruises

WARNINGS

WARNINGS SECTION

For external use only

Flammable: Keep away from excessive heat and open flame

Ask a doctor before use if you have: Sensitive skin

When using this product: Avoid contact with eyes or mucous membranes

Do not apply to wounds or damaged skin
Do not use with other ointments, creams, sprays, or liniments
Do not apply to irritated skin or if excessive irritation develops
Do not bandage
Wash hands after use with cool water
Do not use with heating pad or device

Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If pregnant or breast-feeding: Ask a doctor before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults 18 years of age and older: Massage into skin at affected areas before bed & when symptoms arise

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, SD Alcohol, Carbomer, Olive Oil, Tetrasodium EDTA, Spearmint Oil, Lemongrass oil, Eucalyptus Oil, Peppermint Oil, Camphor, Triethanolamine, F D & C Blue #1, DMDM Hydantoin

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

704-461-3009 • help@fulleight.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBL COOLING GEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2045038	menthol 1.2 % Topical Gel	PSN	13
2045038	menthol 0.012 MG/MG Topical Gel	SCD	13
2045038	menthol 1.2 % Topical Gel	SY	13

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82551-119-14	2025-07-29	C162847	48780-1	3b156c62-28d6-fb37-e063-e6dba90a4e07	FULL EIGHT - COOLING GEL (82551-119)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82551-119-14	COOLING	118 mL in 1 BOTTLE	GEL	118		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82551-119	COOLING (MENTHOL) GEL [FULL EIGHT INC]	13	Legacy NDC, 1 package rows	20241016_d699de4e-f6a8-5255-e053-2a95a90a4fe7.zip

Products#

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

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

COOLING
MENTHOL
CAMPHOR OIL
TROLAMINE
FD&C BLUE NO. 1
DMDM HYDANTOIN
WATER
ALCOHOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
OLIVE OIL
EDETATE SODIUM TETRAHYDRATE
GLYCERIN
SPEARMINT OIL
EAST INDIAN LEMONGRASS OIL
EUCALYPTUS OIL
PEPPERMINT OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82551-119	82551-119-14

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
Name	UNII	Kind
CAMPHOR OIL	75IZZ8Y727	IACT
TROLAMINE	9O3K93S3TK	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
OLIVE OIL	6UYK2W1W1E	IACT
EDETATE SODIUM TETRAHYDRATE	L13NHD21X6	IACT
GLYCERIN	PDC6A3C0OX	IACT
SPEARMINT OIL	C3M81465G5	IACT
EAST INDIAN LEMONGRASS OIL	UP0M8M3VZW	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
MENTHOL	L7T10EIP3A	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2437f019-2700-2cff-e063-6294a90add0a			d699de4e-f6a8-5255-e053-2a95a90a4fe7	2024-10-11	Warnings	Exact identifier spl id: 2437f019-2700-2cff-e063-6294a90add0a spl set id: d699de4e-f6a8-5255-e053-2a95a90a4fe7

Reported adverse events (FAERS/openFDA)#

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