Label: COOL AND HEAT- menthol 16% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-730-04 - Packager: Top Care
- 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 18, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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WarningsFor external use only
Flammable
• do not use while smoking or near heat or flame
• avoid long term storage above 104oF
• do not puncture or incinerate. Contents under pressure
• do not store at temperature above 120oFWhen using this product
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damages skin
• do not bandage tightly
• use only as directedStop use and ask a doctor if
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
•needed for longer than 1 week - Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOL AND HEAT
menthol 16% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-730 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 16 g in 100 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-730-04 113 g in 1 CAN; Type 0: Not a Combination Product 01/22/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/22/2013 Labeler - Top Care (006935977) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(36800-730) , label(36800-730)