COOLING- menthol gel 
FULL EIGHT LLC

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FULL EIGHT - COOLING GEL (82551-119)

ACTIVE INGREDIENT

MENTHOL 1.2%

PURPOSE

TOPICAL ANALGESIC

USE

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

WARNINGS

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

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

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

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

INACTIVE INGREDIENTS

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?

704-461-3009 • help@fulleight.com

LBL COOLING GEL

COOLING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82551-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR OIL (UNII: 75IZZ8Y727)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
GLYCERIN (UNII: PDC6A3C0OX)  
SPEARMINT OIL (UNII: C3M81465G5)  
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82551-119-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/26/2022
Labeler - FULL EIGHT LLC (096786623)

Revised: 1/2024
Document Id: 102dba77-6e4b-bf75-e063-6394a90ac969
Set id: d699de4e-f6a8-5255-e053-2a95a90a4fe7
Version: 12
Effective Time: 20240130
 
FULL EIGHT LLC