Kool Comfort

Dosage form: gel
Ingredients: Menthol 2.5g in 100g
Labeler: Dee Cee Laboratories, Inc.
NDC Code: 52301-365

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Kool Comfort

Active ingredient
Menthol 2.5%

Purpose
Cooling Pain relief

UsesFor 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 informationStore in a cool dry place with lid tightly closed.

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

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





KOOL COMFORT  
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52301-365
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 
ILEX PARAGUARIENSIS LEAF 
EDETOL 
WATER 
ISOPROPYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:52301-365-08226.79 g in 1 JAR
2NDC:52301-365-16453.59 g in 1 JAR
3NDC:52301-365-32907.20 g in 1 JAR
4NDC:52301-365-782211.22 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/05/2012
Labeler - Dee Cee Laboratories, Inc. (034731893)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture(52301-365)

Revised: 07/2012
 
Dee Cee Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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