SOMBRA WARM THERAPY is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Sombra Cosmetics Inc.. The primary component is Camphor (synthetic); Menthol.
| Product ID | 61577-3216_745ebcb7-b9b1-415e-825f-0e72b075d066 |
| NDC | 61577-3216 |
| Product Type | Human Otc Drug |
| Proprietary Name | SOMBRA WARM THERAPY |
| Generic Name | Menthol Camphor |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2022-05-18 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Labeler Name | SOMBRA COSMETICS INC. |
| Substance Name | CAMPHOR (SYNTHETIC); MENTHOL |
| Active Ingredient Strength | 0 g/g; g/g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-05-18 |
| 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 | 2016-06-14 |
| 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 | 2016-06-14 |
| 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 | 2016-06-14 |
| 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 | 2016-06-14 |
| 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 | 2016-06-13 |
| Marketing End Date | 2016-07-11 |
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-06-14 |
| 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 | 2016-06-14 |
| 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 | 2016-06-14 |
| 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 | 2016-06-14 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
| Ingredient | Strength |
|---|---|
| MENTHOL | .03 g/g |
| SPL SET ID: | de78dba9-53b3-4dbd-9dd2-6a692378da34 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 61577-3216 | SOMBRA WARM THERAPY | MENTHOL CAMPHOR |
| 61577-4020 | SOMBRA WARM THERAPY | MENTHOL CAMPHOR |
| 61577-3610 | DEEP REMEDY | MENTHOL CAMPHOR |
| 59321-011 | Gold Edition Ultra Zheng Gu Shui | Menthol Camphor |
| 61577-3501 | GREEN BAMBOO | MENTHOL CAMPHOR |
| 61577-4080 | HealQu Warm Therapy Gel | MENTHOL CAMPHOR |
| 61821-100 | Hua Tuo | Menthol Camphor |
| 73412-001 | Hua Tuo | Menthol Camphor |
| 20276-210 | Lucky Blue Ice | Menthol Camphor |
| 47046-167 | Lucky Blue Ice | Menthol Camphor |
| 61577-2301 | MUSCLE EASE | MENTHOL CAMPHOR |
| 72380-521 | OPITOX TOPICAL | MENTHOL CAMPHOR |
| 61577-7365 | PAIN NO MORE THERAPY | MENTHOL CAMPHOR |
| 61577-5310 | SNAP CRACK | MENTHOL CAMPHOR |
| 61577-7050 | Sombra CBD Warm Therapy | Menthol Camphor |
| 61577-7010 | Sombra Plus CBD 1000mg Warm Theapy | Menthol Camphor |
| 61577-7120 | Sombra Plus CBD 2000mg Warm Theapy | Menthol Camphor |
| 61577-2280 | SORE NO MORE | MENTHOL CAMPHOR |
| 61577-7011 | Sore No More Warm Therapry Plus CBD 1000mg | Menthol Camphor |
| 61577-7012 | Sore No More Warm Therapry Plus CBD 2000mg | Menthol Camphor |
| 61577-7055 | Sore No More Warm Therapy Plus CBD 500mg Natural Pain Relieving Gel | Menthol Camphor |
| 61577-1400 | Tonys Warm Therapy | Menthol Camphor |