Label: METHYL SALICYLATE- methyl salicylate 10% patch
- NDC Code(s): 84460-103-01
- Packager: Florrax Pharmaceutical Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 10, 2025
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- Official Label (Printer Friendly)
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Directions
Adults and children 18 years of age and older:
Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
- Clean and dry affected area
- Open pouch and remove one patch
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal form the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
Fold used patches so that the adhesive side sticks to itself and safely discard used patches of pieces of cut patches where children and pets cannot get to them.
Children under 18 years: Ask a physician
- Purpose
- Uses
- Warnings
- Do not use
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When using this product
- You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensatoin generally disappears after several days.
- Avoid contact with the eyes, lips, nose and mucous membranes
- You may experiences a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
- Avoid contact with the eyes, lips, nose and mucous membranes
- Do not tightly wrap or bandage the treated area
- Do no apply heat to the treated area immediately before or after use
- Stop use and ask a physician if:
- KEEP OUT OF REACH OF CHILDREN
- Active Ingredient
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
METHYL SALICYLATE
methyl salicylate 10% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84460-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84460-103-01 2 in 1 BOX 02/10/2025 1 5 in 1 POUCH 1 100 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 02/10/2025 Labeler - Florrax Pharmaceutical Corp. (119257612)

