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NDC 63187-0078-85 Theragesic Creme 10; 150 mg/g; mg/g Details
Theragesic Creme 10; 150 mg/g; mg/g
Theragesic Creme is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.
Product Information
NDC | 63187-0078 |
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Product ID | 63187-078_34fbc8d2-5ce7-40b2-b342-d33f519bc4c4 |
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 | Theragesic Creme |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | METHYL SALICYLATE |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | TOPICAL |
Active Ingredient Strength | 10; 150 |
Active Ingredient Units | mg/g; mg/g |
Substance Name | MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE |
Labeler Name | Proficient Rx LP |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2022-12-31 |
Package
Package Images

NDC 63187-0078-85 (63187007885)
NDC Package Code | 63187-078-85 |
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Billing NDC | 63187007885 |
Package | 1 TUBE in 1 CARTON (63187-078-85) / 85 g in 1 TUBE |
Marketing Start Date | 2018-11-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 56e88a96-5be0-4a5c-995e-77c807c5294b Details
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients |
Purpose |
Menthol 1%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic |
|
Methyl Salicylate 15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
Adults and children 12 or more years of age. Apply thin layers of crème into and around the sore or painful area, not more than 3 to 4 times daily. The number of thin layers controls the intensity of the action of THERA-GESIC®. One this layer provides a mild effect, two thin layers provide a strong effect and three thin layers provide a very strong effect. SEE WARNINGS. Wash hands thoroughly after application.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SHARE BEFORE USE: IT IS NORMAL FOR THIS PRODUCT TO GIVE THE IMPRESSION OF A LIQUID SOUND UON SHAKING. DO NOT ALLOW THERA-GESIC® TO COMEIN CONTACT WITH ANY SURFACE, OTHER THAN SKIN.
Do not use this product if tube is punctured. Lot number and expiration date on end of carton.
MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355
50588 03 Rev 001090
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
INGREDIENTS AND APPEARANCE
THERAGESIC CREME
methyl salicylate gel |
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Labeler - Proficient Rx LP (079196022) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Proficient Rx LP | 079196022 | REPACK(63187-078) , RELABEL(63187-078) |