DUANE READE HOT AND COLD BALM- methyl salicylate and menthol salve 
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

Allergy alert:

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

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

petrolatum, paraffin

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DR_hot_and_cold_balm_label

DUANE READE  HOT AND COLD BALM
methyl salicylate and menthol salve
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 SALICYLATE30.16 mL  in 104 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.90 mL  in 104 mL
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-023-02104 mL in 1 CANISTER
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: 765259a5-6d84-4145-b9e3-3a6dd5206c4a
Set id: cc429935-095f-49ac-a847-24d8f5c95523
Version: 1
Effective Time: 20110228
 
Duane Reade