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NDC 50488-2010-01 Methyl Salicylate 10 g/100g Details
Methyl Salicylate 10 g/100g
Methyl Salicylate is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is METHYL SALICYLATE.
Product Information
| NDC | 50488-2010 |
|---|---|
| Product ID | 50488-2010_b40f677d-3b13-4e6d-8800-b7ba6443c67a |
| Associated GPIs | 90800050005920 |
| GCN Sequence Number | 082330 |
| GCN Sequence Number Description | methyl salicylate ADH. PATCH 10 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 49718 |
| HICL Sequence Number | 002595 |
| HICL Sequence Number Description | METHYL SALICYLATE |
| Brand/Generic | Generic |
| Proprietary Name | Methyl Salicylate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Methyl Salicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | g/100g |
| Substance Name | METHYL SALICYLATE |
| Labeler Name | Alexso, Inc |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 50488-2010-01 (50488201001)
| NDC Package Code | 50488-2010-1 |
|---|---|
| Billing NDC | 50488201001 |
| Package | 2 POUCH in 1 BOX (50488-2010-1) / 5 PATCH in 1 POUCH / 100 g in 1 PATCH |
| Marketing Start Date | 2021-02-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bac67f94-8627-47ff-a736-37feab77330a Details
Uses
Warnings
For external use only. Use only as directed or as directed by a health care professional.
Read all warnings and directions before use.
Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.
Do not use:
• On wounds, cuts, damaged or infected skin
• On eyes, mouth, genitals, or any other mucous membranes
When using this product
- Avoid contact with the eyes
- You may experience 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 not apply heat to the treated area immediately before or after use
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 the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from 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 or pieces of cut patches where children and pets cannot get to them.
Children under 18 years: Ask a physician
Other information
Inactive ingredients
INGREDIENTS AND APPEARANCE
| METHYL SALICYLATE
methyl salicylate patch |
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| Labeler - Alexso, Inc (963338061) |