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

adults and children 12 years of age and older

children under 12 years of age

Other information

Inactive Ingredients

1,3- butylene glycol, alove vera (powder), dibutylhydroxytoluene, disodium edetate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purifed water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

Distributed By:

Topco Associates LLC

150 Northwest Point Boulevard

Elk Grove Village, IL 60007

Made in Korea

image description

TOP CARE MEDICATED 
menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-155
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 750 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SORBITOL (UNII: 506T60A25R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MAGALDRATE (UNII: 6V88E24N5T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-155-05 1 in 1 CARTON 02/07/2017
1 5 in 1 POUCH; Type 0: Not a Combination Product
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: 2/2017
Document Id: e6f83126-0fc3-4fb5-8d44-208f1cba7a8b
Set id: 9d5e73ed-41f2-4f54-ae07-46124ff54cb8
Version: 4
Effective Time: 20170207
 
Top Care