ATOPALM MUSCLE AND JOINT- menthol gel

ATOPALM MUSCLE AND JOINT by

Drug Labeling and Warnings

ATOPALM MUSCLE AND JOINT 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 Ingredients

Menthol 2.5%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses temporarily relieves the 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
  

Ask a doctor before use if you have redness over the affected area.

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly
  

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs
  

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

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

children under 12 years of age
ask a doctor

STORAGE AND HANDLING

Other Information

• store at 68 - 77 degree Fahrenheit (20 - 25 degrees Celsius)
• see end of carton or tube crimp for lot number and expiration date
  

INACTIVE INGREDIENT

Inactive Ingredients

WATER, GLYCERIN, ISOPROPYL ALCOHOL, STEARIC ACID, CARBOMER, CAMPHOR, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CHOLESTEROL, METHYLPARABEN, POLYSORBATE 60, TRIETHANOLAMINE

QUESTIONS

Questions? Call 1-855-ATOPALM

SPL UNCLASSIFIED SECTION

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

Made in Korea

PRINCIPAL DISPLAY PANEL

Pain Relieving Gel                 VANISHING SCENT

Deep pain relief for minor arthritis pain, sore, aching, strained muscles and simple backache.
Helps target pain at the source. Vanishing scent makes product ideal for daytime use.

Vanishing Scent

ATOPALM (TM)

MUSCLE AND JOINT GEL

Menthol 2.5%

Pain Relief in moisturizing Gel based on US Patented MLE Technology

Net Wt. 4 oz/113 g

INGREDIENTS AND APPEARANCE

ATOPALM MUSCLE AND JOINT 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
STEARIC ACID (UNII: 4ELV7Z65AP)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHOLESTEROL (UNII: 97C5T2UQ7J)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0240-4	1 in 1 CARTON
1		113 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(51141-0240)