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

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

When using this product

• use only as directed
• avoid contact with eyes or mucous membranes
• do not bandage tightly or use 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

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.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

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

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	21.46 mL  in 74 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.62 mL  in 74 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-023-03	74 mL in 1 BOTTLE, WITH APPLICATOR

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