Duane Reade hot and cold balm

Dosage form: salve
Ingredients: METHYL SALICYLATE 30.16mL in 104mL, MENTHOL 7.90mL in 104mL
Labeler: Duane Reade
NDC Code: 24488-023

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 Facts

Active Ingredients Purpose

Methyl Salicylate 29% ...Topical Analgesic
Menthol 7.6% ................Topical Analgesic

Uses

temporarily relieves the minor pains associated with:

  • arthritis
  • cramps
  • bruises
  • sprains
  • backache

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
  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly or with a heating pad
  • do not apply to wounds or damaged 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:
  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily
children under 12 years: ask a doctor.

Inactive ingredients

petrolatum, paraffin

Placeholder text

DUANE READE  HOT AND COLD BALM
methyl salicylate and menthol salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE30.16 mL  in 104 mL
MENTHOL (MENTHOL) MENTHOL7.90 mL  in 104 mL
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
PARAFFIN 
Packaging
#Item CodePackage Description
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/FEIOperations
Creations Garden Natural Products Inc.961956229manufacture

Revised: 02/2011
 
Duane Reade

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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