ATOPALM PAIN RELIEVING - menthol cream 
NeoPharm Co., Ltd.

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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ATOPALM PAIN RELIEVING CREAM

Drug Facts

Active ingredient

Menthol 10%

Purpose

Topical Analgesic

Uses For temporary relief of minor aches and pains of muscles and joints associated with

Warnings For external use only.

Do not use

Stop use and ask a doctor if

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.

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

Directions

adults and children 12 years of age and older
apply to affected area not more than 3 to 4 times daily

Children under 12 years of age
ask a doctor

Inactive Ingredients

WATER, GLYCERIN, CETYL ALCOHOL, POLYSORBATE 60, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, ISOPROPYL MYRISTATE, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CARBOMER, TRIETHANOLAMINE, CHOLESTEROL, ALOE VERA GEL, METHYLPARABEN, PROPYLPARABEN.

Other Information

store at 20 - 25 degrees Celsius (68 - 75 degrees Fahrenheit)

see carton or flap or tube crimp for  lot number and expiration date

Questions or information call toll free: 1-855-ATOPALM

US Patent # US 6221371B1

Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760

Made in Korea

Pain Relieving Cream
Non-Greasy, Non-Staining

10% Menthol
Ultra-light Nighttime Scent

DEEP PENETRATING PAIN RELIEF

ATOPALM (TM)

Developed for Nighttime Use

Goes on smoothly and leaves skin feeling soft and smooth

Net. Wt. 2 oz/57 g

Specially Formulated with US Patented MLE Technology


ATOPALM pain relieving cream outer package

ATOPALM pain relieving cream tube

ATOPALM PAIN RELIEVING 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0239
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
TROLAMINE (UNII: 9O3K93S3TK)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0239-21 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/14/2012
Labeler - NeoPharm Co., Ltd. (965502912)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture(51141-0239)

Revised: 8/2012
Document Id: 0bb2e368-a9b1-4db4-929a-73afbdd08c7d
Set id: 37af7fb3-d308-44ca-9bff-05d9a2a6ca14
Version: 2
Effective Time: 20120815
 
NeoPharm Co., Ltd.