Label: METHYL SALICYLATE 10%- methyl salicylate patch
- NDC Code(s): 82944-101-10
- Packager: ION PHARMA, LLC
- 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.
Drug Label Information
Updated June 5, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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- Active ingredients:
- 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 as NSAID (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
Do 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)
- any patch from a pouch that has been open for 14 or more days
- right before or after heat surgery
Ask a doctor before use if
- you are allergic to topical products
- the stomach bleeding warning applies to you
- you are taking a diuretic
- you have high blood pressure, heart disease or kidney disease
When using this product
- wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with the water.
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Stop 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 days.
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Directions
Adults and Children 10 years of age and older:
- only use one patch at a time
- clean and dry affected area
- remove patch from backing film and apply to skin (see illustration)
- apply 1 patch to the affective area of intact skin up to 36 hours.
- do not use more than 2 patches per day
- do not use for more than 3 days in a row
- the used patch should be removed from the skin when a new one is applied
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
NDC 82944-101-10
METHYL SALICYLATE 10%
Topical Analgesic (NSAID)TOPICAL PAIN PATCH
For Temporary Pain Relief
Flexible Patch Innovation
Soothing and Effective
Long Lasting ReliefWATER
RESISTANT
TECHNOLOGYQty: 10 Flexible Patches
(5 Per Resealable Pouch) x2
3 x 5 (7.62cm x 12.7cm)APPLY FOR 36 HOURS
ION PHARMA
MADE IN
USA
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INGREDIENTS AND APPEARANCE
METHYL SALICYLATE 10%
methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82944-101 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 Inactive Ingredients Ingredient Name Strength ACRYLIC ACID (UNII: J94PBK7X8S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82944-101-10 10 in 1 BOX 06/01/2023 1 5 in 1 POUCH; 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 06/01/2023 Labeler - ION PHARMA, LLC (118739596)