Label: FOOT REHAB PAIN RELIEF AND MOISTURIZER MISSION- menthol, methyl salicylate cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 12, 2013
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Active Ingredient Purpose
Menthol 10% Topical Analgesic
Methyl Salicylate 15 % Topical Analgesic
Temporarily relieves minor aches and pains of muscles and joints associated with
- simple backache
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
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
-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
- PRINCIPAL DISPLAY PANEL
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)