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NDC 63299-0001-01 MENTHOL AND METHYL SALICYLATE 16; 32 g/100g; g/100g Details
MENTHOL AND METHYL SALICYLATE 16; 32 g/100g; g/100g
MENTHOL AND METHYL SALICYLATE is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by FEI FAH MEDICAL MANUFACTURING PTE LTD. The primary component is MENTHOL; METHYL SALICYLATE.
Product Information
NDC | 63299-0001 |
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Product ID | 63299-001_310f812b-cd56-45f6-b022-26baff9f0cd0 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | MENTHOL AND METHYL SALICYLATE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ELECTRIC MEDICATED BALM ULTRA STRENGTH |
Product Type | HUMAN OTC DRUG |
Dosage Form | OINTMENT |
Route | TOPICAL |
Active Ingredient Strength | 16; 32 |
Active Ingredient Units | g/100g; g/100g |
Substance Name | MENTHOL; METHYL SALICYLATE |
Labeler Name | FEI FAH MEDICAL MANUFACTURING PTE LTD |
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 63299-0001-01 (63299000101)
NDC Package Code | 63299-001-01 |
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Billing NDC | 63299000101 |
Package | 1 JAR in 1 BOX (63299-001-01) / 70 g in 1 JAR |
Marketing Start Date | 2018-03-28 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 91e6d3b9-25bb-4015-9d96-bd27f93e5ada Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive irritation of the skin develops
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
when using for pain of arthritis
pain persists for more than 10 days
redness is present
in conditions affecting children under 12 years of age
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
MENTHOL AND METHYL SALICYLATE
electric medicated balm ultra strength ointment |
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Labeler - FEI FAH MEDICAL MANUFACTURING PTE LTD (628416141) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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FEI FAH MEDICAL MANUFACTURING PTE LTD | 628416141 | manufacture(63299-001) |
Revised: 3/2018
Document Id: 310f812b-cd56-45f6-b022-26baff9f0cd0
Set id: 91e6d3b9-25bb-4015-9d96-bd27f93e5ada
Version: 1
Effective Time: 20180328