ARTHRIPAIN RELIEF - menthol cream
NDI Solutions LLC

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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Drug Facts

Active Ingredient Purpose

Menthol 1.25%.................................................................Pain relieving cream

Use Temporarily relieves minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only

Do not use

on wounds or damaged skin

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

Keep out of reach of children

Directions

Adult and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Consult a physician.

Inactive Ingredients: aloe vera gel, cetyl alcohol, cetyl esters
(proprietary blend of esterfied fatty acids)(7.5%), cinnamon oil,
eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba
oil, peppermint oil, potassium sorbate, purified water, squalane, stearic
acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.

ArthriPain packaging

package including display panel

ARTHRIPAIN RELIEF
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50972-278
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	12.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cetyl Alcohol (UNII: 936JST6JCN)
Cetyl Esters Wax (UNII: D072FFP9GU)
Cinnamon Oil (UNII: E5GY4I6YCZ)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GRAPE SEED OIL (UNII: 930MLC8XGG)
HYPROMELLOSE (UNII: 3NXW29V3WO)
JOJOBA OIL (UNII: 724GKU717M)
PEPPERMINT OIL (UNII: AV092KU4JH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL SALICYLATE (UNII: LAV5U5022Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50972-278-01	57 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/01/2010

Labeler - NDI Solutions LLC (828825989)