CAREONE EXTRA STRENGTH COLD AND HOT- menthol patch 
American Sales Company

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 Poision Control Center right away

Directions

adults and children over 12 years:

children 12 years or younger: consult a doctor

Other information

Inactive ingredients

alove vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate,  methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non-waven fabric

Distributed by:

Foodhold U.S.A., LLC

Landover, MD 20785

Made in Korea

image description

CAREONE EXTRA STRENGTH COLD AND HOT 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-871
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 mg
Inactive Ingredients
Ingredient NameStrength
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)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-871-055 in 1 CARTON05/10/2017
11 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/16/2014
Labeler - American Sales Company (809183973)

Revised: 11/2019
Document Id: 97686ef1-f3f9-cf31-e053-2995a90ae3e8
Set id: 1b66857c-38fb-49b5-a438-533c02aba4cc
Version: 3
Effective Time: 20191115
 
American Sales Company