DUANE READE HOT AND COLD ROLL-ON- methyl salicylate and menthol gel 
Duane Reade

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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Drug Facts

Active Ingredients Purpose

Methyl Salicylate 29% .......................................................Topical Analgesic

Menthol 7.6% ....................................................................Topical Analgesic

Uses

temporarily relieves the minor pains associated with:

Warnings

For external use only

When using this product

Stop use and ask a doctor if

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:

children under 12 years: ask a doctor

Inactive ingredients

purified water/aqua/eau, sd alcohol 40-b,

propylene glycol, isopropyl myristate,

glycerin, triethanolamine, carbomer

Allergy alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

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DR_Hot-n-Cold_Rollon_label
DUANE READE  HOT AND COLD ROLL-ON
methyl salicylate and menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE21.46 mL  in 74 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.62 mL  in 74 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-023-0374 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/28/2011
Labeler - Duane Reade (961956229)
Registrant - Creations Garden Natural Products Inc. (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creations Garden Natural Products Inc.961956229manufacture

Revised: 2/2011
Document Id: fcbcce35-b447-4d0e-b5e1-06afaee3f5ea
Set id: d4a02427-127f-4d76-9c02-bf2efcc84c78
Version: 1
Effective Time: 20110225
 
Duane Reade