COOL N HEAT PATCH FOR ARM, NECK AND LEG EXTRA STRENGTH- menthol patch 
Walgreen Co.

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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Menthol 5% (Topical Analgesic)

Active ingredient

Menthol 5%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

Warnings

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
adults and children 12 years of age and older

children under 12 years of age consult a doctor

Other information

Inactive ingredients

aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

Questions or comments? 1-800-WALGREENS (1-800-925-4733)

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COOL N HEAT PATCH FOR ARM, NECK AND LEG  EXTRA STRENGTH
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol.05 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Edetate Disodium (UNII: 7FLD91C86K)  
Gelatin (UNII: 2G86QN327L)  
Kaolin (UNII: 24H4NWX5CO)  
Methylparaben (UNII: A2I8C7HI9T)  
Glycerin (UNII: PDC6A3C0OX)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Water (UNII: 059QF0KO0R)  
PEG-4 Stearate (UNII: J33E8608YN)  
Polyvinyl Alcohol (UNII: 532B59J990)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Silodrate (UNII: 9T3UU8T0QK)  
Castor Oil (UNII: D5340Y2I9G)  
Tartaric Acid (UNII: W4888I119H)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0150-015 in 1 BOX
11 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/15/2013
Labeler - Walgreen Co. (008965063)

Revised: 10/2013
Document Id: b413af71-fd41-4fe6-a91b-8fb14a3fda74
Set id: f833dd00-0c87-435f-a2e3-7b0d63e0ea1d
Version: 5
Effective Time: 20131010
 
Walgreen Co.