COOLING by FULL EIGHT LLC COOLING- menthol gel

COOLING by

Drug Labeling and Warnings

COOLING by is a Otc medication manufactured, distributed, or labeled by FULL EIGHT LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82551-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82551-119-14	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/26/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/26/2022

Labeler - FULL EIGHT LLC (096786623)