PAIN RELIEVING PATCH ULTRA STRENGTH  ULTRA STRENGTH- menthol patch 
CVS PHARMACY, INC.

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 aches and pains of muscles and joints associated with:

Warnings

For external use only

Do not use

Ask a doctor before use if you

When using this product

Stop using this product if

If pregnant or breastfeeding consult a healthcare professional before use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients BHT, castor oil, cellulose gum, disodium edetate, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide. Release Liner: polyethylene, Non-Woven Material: polyester non-woven fabric.

Questions? Call toll-free 1-800-645-3867


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PAIN RELIEVING PATCH ULTRA STRENGTH   ULTRA STRENGTH
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-991
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Silodrate (UNII: 9T3UU8T0QK)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Castor Oil (UNII: D5340Y2I9G)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Edetate Disodium (UNII: 7FLD91C86K)  
Gelatin (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Kaolin (UNII: 24H4NWX5CO)  
Methylparaben (UNII: A2I8C7HI9T)  
Peg-4 Stearate (UNII: J33E8608YN)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Polyvinyl Alcohol (UNII: 532B59J990)  
Water (UNII: 059QF0KO0R)  
Tartaric Acid (UNII: W4888I119H)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-991-015 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 - CVS PHARMACY, INC. (062312574)

Revised: 9/2013
Document Id: bcbfe1f1-6e96-4f45-bd96-79a84b94e193
Set id: 189c313d-f0a3-4593-852e-addbe9082524
Version: 17
Effective Time: 20130918
 
CVS PHARMACY, INC.