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ICY HOT MEDICATED ROLL, MEDIUM (menthol) patch
ICY HOT MEDICATED ROLL, LARGE (menthol) patch
[Nichiban Company Limited]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Active ingredient

Menthol 7.5%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

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

Stop use and ask a doctor if:

  • condition worsens
  • redness is present
  • irritation develops
  • 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 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

Keep carton as it contains important information for usage of this product.

Distributed by Chattem, Inc.

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

© 2009 www.icyhot.com

MADE IN JAPAN
[NDC Code]

Principal Display Panel - Medium Roll, Pouch

 Reseal Pouch After Opening

ICY HOT® MEDICATED ROLL
Menthol 7.5%

CUSTOMIZED PAIN RELIEF

  • Tear or Cut to Any Length
  • Lasts up to 8 Hours
  • Comfortable, Flexible, Stays in Place

EXTRA STRENGTH
MEDIUM - 2"

Pain Relieving Ointment on Breathable, Flexible Fabric

2" x 60" (5 cm x 150 cm)

Principal Display Panel - Medium Roll Pouch

Medium Roll Pouch

Principal Display Panel - Large Roll, Pouch

Reseal Pouch After Opening

ICY HOT® MEDICATED ROLL
Menthol 7.5%

CUSTOMIZED PAIN RELIEF

  • Tear or Cut to Any Length
  • Lasts up to 8 Hours
  • Comfortable, Flexible, Stays in Place

EXTRA STRENGTH
LARGE - 3"

Pain Relieving Ointment on Breathable, Flexible Fabric

3" x 43" (7.5 cm x 110 cm)

Principal Display Panel - Large Roll Pouch

Large Roll Pouch

INGREDIENTS & APPEARANCE

ICY HOT  MEDICATED ROLL, MEDIUM
menthol patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:44014-085
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL787.5 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44014-085-011 in 1 POUCH
2NDC:44014-085-03170 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2009
ICY HOT  MEDICATED ROLL, LARGE
menthol patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:44014-086
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL866.25 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44014-086-071 in 1 POUCH
2NDC:44014-086-02150 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2009
Labeler - Nichiban Company Limited (690544325)
Establishment
NameAddressID/FEIBusiness Operations
Nichiban Company Limited690544325ANALYSIS, MANUFACTURE

Revised: 12/2009
 
Nichiban Company Limited