TOP CARE MEDICATED - menthol patch 
Top Care

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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Active ingredient                                                                              Purpose

Menthol 5%.......................................................................Topical Analgesic

Uses Temporarily relieves minor pain associated with:

Warnings For external use only

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.

If pregnant or breast-feeding, ask a health professional before use.

Directions

Other information

Inactive Ingredients aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminu hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, tocopherol acetate, sodium polyacrylate, tartaric acid, titanium dioxide. Release Liner: polypropylene. Non-Woven Material: polyester non-woven fabric.

Distributed By:

Topco Associates LLC

150 Northwest Point Boulevard

Elk Grove Village, IL 60007


image description

TOP CARE MEDICATED 
menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-155
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 750 mg
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CASTOR OIL (UNII: D5340Y2I9G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-155-05 1 in 1 CARTON
1 5 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/21/2014
Labeler - Top Care (006935977)

Revised: 4/2014
Document Id: 7ec28230-1ccf-495f-a8b3-48a3f54ae8b7
Set id: 9d5e73ed-41f2-4f54-ae07-46124ff54cb8
Version: 3
Effective Time: 20140421
 
Top Care