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

Duane Reade by

Drug Labeling and Warnings

Duane Reade by is a Otc medication manufactured, distributed, or labeled by Duane Reade, Creations Garden Natural Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

DUANE READE  HOT AND COLD BALM
methyl salicylate and menthol salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	30.16 mL  in 104 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.90 mL  in 104 mL

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-023-02	104 mL in 1 CANISTER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/28/2011

Labeler - Duane Reade (961956229)

Registrant - Creations Garden Natural Products Inc. (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products Inc.		961956229	manufacture