KOOL COMFORT  - menthol gel 
Dee Cee Laboratories, Inc.

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.

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Kool Comfort

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

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.

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 Labeling





KOOL COMFORT  
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52301-365
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
EDETOL (UNII: Q4R969U9FR)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Great Southern Laboratories056139553manufacture(52301-365)

Revised: 7/2012
Document Id: 4aa767e7-6691-406a-9906-4b40ba27d8e2
Set id: 996c0e13-5f36-4779-99db-b893b482597b
Version: 1
Effective Time: 20120705
 
Dee Cee Laboratories, Inc.