KOOL COMFORT- menthol gel

Kool Comfort by

Drug Labeling and Warnings

Kool Comfort by is a Otc medication manufactured, distributed, or labeled by Dee Cee Laboratories, Inc., Great Southern Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Menthol 2.5%

Purpose
Cooling Pain relief

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with · simple backache · arthritis ·strains · bruises · sprains

Warnings

For external use only.

Flammable
Keep away from excessive heat or open flame.

Ask a doctor before use if you have

• sensitive skin
  

When using this product

• avoid contact with the 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 heating devices
  

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years of age and over:  apply to affected area not more than 3 to 4 times daily
• Children under 2 years of age:  Consult a physician.
  

Other information

Store in a cool dry place with lid tightly closed.

Inactive ingredients

carbopol 934, FD&C blue #1, esi-cryll ll, herbal extract (ILEX paraguariensis), isopropyl alcohol, neutrol TE, phenonip, and purified water.

SPL UNCLASSIFIED SECTION

Lot. No. & Exp. Date:  See label or bottom of container.
Manufactured for:
Dee Cee Laboratories Inc., 304 Dee Cee Ct., White House, TN  37188

Product Packaging

INGREDIENTS AND APPEARANCE

KOOL COMFORT  
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52301-365
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
EDETOL (UNII: Q4R969U9FR)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52301-365-08	226.79 g in 1 JAR
2	NDC: 52301-365-16	453.59 g in 1 JAR
3	NDC: 52301-365-32	907.20 g in 1 JAR
4	NDC: 52301-365-78	2211.22 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/05/2012

Labeler - Dee Cee Laboratories, Inc. (034731893)

Registrant - Great Southern Laboratories (056139553)

Establishment
Name	Address	ID/FEI	Business Operations
Great Southern Laboratories		056139553	manufacture(52301-365)