FDA Label for Atopalm Pain Relieving
View Indications, Usage & Precautions
Atopalm Pain Relieving Product Label
The following document was submitted to the FDA by the labeler of this product Neopharm Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
US Patent # US 6221371B1
Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760
Made in Korea
Otc - Active Ingredient
Active ingredient
Menthol 10%
Otc - 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
Otc - 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.
Otc - When Using
When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.
Otc - 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
Directionsadults and children 12 years of age and olderapply to affected area not more than 3 to 4 times dailyChildren under 12 years of ageask 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
Otc - Questions
Questions or information call toll free: 1-855-ATOPALM
Package Label.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
* Please review the disclaimer below.