FOOT REHAB PAIN RELIEF AND MOISTURIZER MISSION- menthol, methyl salicylate cream

Foot Rehab Pain relief and moisturizer by

Drug Labeling and Warnings

Foot Rehab Pain relief and moisturizer by is a Otc medication manufactured, distributed, or labeled by Mission Product Holdings, Neopharm CO. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Menthol 10% Topical Analgesic

Methyl Salicylate 15 % Topical Analgesic

Uses:

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

- simple backache

- arthritis

- strains

- bruises

- sprains

Keep out of the reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center immediately.

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

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

Directions

-Use only as directed

adults and children 12 years of age or older

- Apply to affected area not more than 3 to 4 time daily.

Children under 12 years of age -ask a doctor

Inactive ingredients: Water, Glycerin, Cetyl aclohol, PEG-15 Glyceryl Stearate,Glyceryl Stearate, Stearic acid, Stearyl Alcohol, Myristoyl/palmitoyloxostearamide/Arachamide MEA, Carbomer 940, Cholesterol, Trolamine, Isopropyl Myristate, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL

Mission

Foor Rehab™ Pain relief & moisturizer

fast temporary relief from minor foot pain

non greasy formula

10% Menthol

Dual Action: Pain relief & moisturizing

Net Wt 3 oz // 85 G

INGREDIENTS AND APPEARANCE

FOOT REHAB PAIN RELIEF AND MOISTURIZER  MISSION
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76347-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.5 g  in 85 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	12.75 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76347-120-01	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/05/2012

Labeler - Mission Product Holdings (808672120)

Registrant - Mission Product Holdings (808672120)

Establishment
Name	Address	ID/FEI	Business Operations
Neopharm CO. Ltd		631101883	manufacture(76347-120)