Label: METHYL SALICYLATE cream
- NDC Code(s): 79643-004-01
- Packager: PHARMACURE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 15, 2024
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- Official Label (Printer Friendly)
- Active Ingredient Purpose
- PURPOSE
- Uses
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Warnings
For external use only
Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding.
The chance is small but higher if you:• are age 60 or older • have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directedDo not use
• on the face or rashes • on wounds or damaged skin • if allergic to aspirin or other NSAIDs
• with a heating pad • when sweating (such as from exercise or heat)
• right before or after heart surgeryAsk a doctor before use if
• you are allergic to topical products • the stomach bleeding warning applies to you
• you have high blood pressure, heart disease, or kidney disease • you are taking a diureticWhen using this product
• wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directedStop use and ask a doctor if
• stomach pain or upset gets worse or lasts • you feel faint, vomit blood, or have bloody or black stools
These are signs of stomach bleeding. • rash, itching or skin irritation develops
• condition worsens
• symptoms last for more than 3 days • symptoms clear up and occur again within a few daysIf pregnant or breast-feeding,
ask a doctor before use while breast-feeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together. - KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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Inactive ingredients
Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbital olivate, stearic acid
- Product label
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INGREDIENTS AND APPEARANCE
METHYL SALICYLATE
methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79643-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 250 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HEMP (UNII: TD1MUT01Q7) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) RESVERATROL (UNII: Q369O8926L) SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y) SORBITAN OLIVATE (UNII: MDL271E3GR) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79643-004-01 100 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/01/2024 Labeler - PHARMACURE LLC (055983858)