ATOPALM PAIN RELIEVING- menthol cream

ATOPALM PAIN RELIEVING by

Drug Labeling and Warnings

ATOPALM PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Menthol 10%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

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

• simple backache
• arthritis
• strains
• bruises
• sprains
  

WARNINGS

Warnings For external use only.

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis like conditions
  

STOP USE

Stop use and ask a doctor if

• conditions worsen
  
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs
• have redness over the affected area.
  

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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.

STORAGE AND HANDLING

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

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

SPL UNCLASSIFIED SECTION

US Patent # US 6221371B1

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

Made in Korea

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ATOPALM PAIN RELIEVING 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0239-2	1 in 1 CARTON
1		57 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/14/2012

Labeler - NeoPharm Co., Ltd. (965502912)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture(51141-0239)