SOMBRA COOL THERAPY is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Sombra Cosmetics Inc.. The primary component is Menthol.
| Product ID | 61577-3221_443a475e-c42d-45a1-9e93-013b9519e519 |
| NDC | 61577-3221 |
| Product Type | Human Otc Drug |
| Proprietary Name | SOMBRA COOL THERAPY |
| Generic Name | Menthol |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2016-04-29 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Labeler Name | SOMBRA COSMETICS INC. |
| Substance Name | MENTHOL |
| Active Ingredient Strength | 0 g/g |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2022-05-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2016-05-21 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2016-05-21 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2016-05-21 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-21 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-21 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-21 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2016-04-29 |
| Marketing End Date | 2016-06-29 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-21 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-21 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Ingredient | Strength |
|---|---|
| MENTHOL | .06 g/g |
| SPL SET ID: | 87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 61577-3221 | SOMBRA COOL THERAPY | SOMBRA COOL THERAPY |
| 61577-4030 | SOMBRA COOL THERAPY | SOMBRA COOL THERAPY |
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