Label: KOOL COMFORT- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 52301-365-08, 52301-365-16, 52301-365-32, 52301-365-78 - Packager: Dee Cee Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 5, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
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Warnings
For external use only.
Flammable
Keep away from excessive heat or open flame.
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
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Product Packaging
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INGREDIENTS AND APPEARANCE
KOOL COMFORT
menthol gelProduct 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)