Label: ICY HOT MEDICATED ROLL, MEDIUM- menthol patch
ICY HOT MEDICATED ROLL, LARGE- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 44014-085-01, 44014-085-03, 44014-086-02, 44014-086-07 - Packager: Nichiban Company Limited
- 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 December 23, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings:
For external use only
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- do not overwrap or wrap strips over themselves
- do not wrap around neck
- do not apply over large areas of the body or apply in strips longer than 6 inches
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
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Directions:
adults and children over 12 years:
- tear or cut roll to desired size
- carefully remove backing from one end of strip and place on affected area
- remove remaining backing and press into place
- wear Icy Hot Medicated Roll for up to 8 hours
- repeat as necessary, but no more than 3 to 4 times daily
children 12 years or younger: ask a doctor
- SPL UNCLASSIFIED SECTION
- Principal Display Panel - Medium Roll, Pouch
- Principal Display Panel - Large Roll, Pouch
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INGREDIENTS AND APPEARANCE
ICY HOT MEDICATED ROLL, MEDIUM
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44014-085 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 787.5 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44014-085-01 1 in 1 POUCH 2 NDC:44014-085-03 170 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2009 ICY HOT MEDICATED ROLL, LARGE
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44014-086 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 866.25 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44014-086-07 1 in 1 POUCH 2 NDC:44014-086-02 150 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2009 Labeler - Nichiban Company Limited (690544325) Establishment Name Address ID/FEI Business Operations Nichiban Company Limited 690544325 ANALYSIS, MANUFACTURE
