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 | 61577-4030_616a9712-77f7-55f5-e053-2991aa0a46e9 |
| NDC | 61577-4030 |
| Product Type | Human Otc Drug |
| Proprietary Name | SOMBRA COOL THERAPY |
| Generic Name | Menthol |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2017-10-20 |
| 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 | 2017-10-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-10-20 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-06 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-10-20 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-06 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-10-20 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-06 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-10-20 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-06 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-10-20 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-06 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-10-20 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-06 |
| Ingredient | Strength |
|---|---|
| MENTHOL | .06 g/g |
| SPL SET ID: | a2d403f7-aad0-4692-a36f-ee25a84a013f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| 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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