Label: FAST RELIEF ARTROSAMIN- menthol, methyl salicylate cream
- NDC Code(s): 69706-0203-9
- Packager: Interfarma Corp
- 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 October 1, 2015
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- DRUG FACTS
Active Ingredient: Purpose:
Menthol 2.5%...................................External Analgesic
Methyl Salicylate 15%......................External AnalgesicClose
Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.Close
- For external use only.
- Do not use this product if safety seal is broken. Store in room temperature.
- Do not use on wounds or damaged skin. Do not apply in large quantities, particularly on raw and irritated or blistered areas.
- When using this product, avoid contact with eyes or mucus membranes. Use only as directed. Do not bandage tightly.
- Stop and ask doctor if condition worsen, if symptoms persist within 7 days or clear up and occur again within a few days. Stop use if excessive skin irritation occurs.
- If pregnant or breast feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children to avoid accidental poisoning.Close
- DOSAGE & ADMINISTRATION
Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or mucous membranes. If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.Close
Apply to the affected area. Gently massage into the skin for a few seconds. Adults and children over 12 years of age: apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age need to consult a physician.Close
- Inactive Ingredients:
Acrymalide, Amino Acids, Comfrey Leaf, Cetyl Alcohol, Diazolidinyl Urea, Dimethicone, Glucosamine, Methyl Paraben, MSM (Methylsulfonylmethane), Mineral Oil, Panthenol, Propylene Glycol, Propylparaben, Sodium Pyrrolidone Carboxylate, Stearic Acid, Stearyl Alcohol, Trolamine, Water.Close
- Manufactured for:
Miami, FL 33186.Close
- FAST RELIEF ARTROSAMIN
For Temporarily Relieves minor aches and pains soreness, and stiffness associated with simple backaches strains, arthritis and rheumatism.
Net Wt 8 oz (226g)
Made in USA
- INGREDIENTS AND APPEARANCE
FAST RELIEF ARTROSAMIN
menthol, methyl salicylate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69706-0203 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 METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength ACRYLAMIDE (UNII: 20R035KLCI) AMINO ACIDS, WHEAT (UNII: 0370GZL32F) CETYL ALCOHOL (UNII: 936JST6JCN) COMFREY LEAF (UNII: DG4F8T839X) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) GLUCOSAMINE (UNII: N08U5BOQ1K) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PANTHENOL (UNII: WV9CM0O67Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69706-0203-9 226 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/11/2013 Labeler - Interfarma Corp (884091703) Registrant - Interfarma Corp (884091703) Establishment Name Address ID/FEI Business Operations Interfarma Corp 884091703 manufacture(69706-0203)