NDC 70338-641
PainZone
External Analgesic
PainZone is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Medzone Products Llc. The primary component is Camphor, (-)-; Menthol; Methyl Salicylate.
| Product ID | 70338-641_6507bf97-6250-234b-e053-2991aa0a2d18 |
| NDC | 70338-641 |
| Product Type | Human Otc Drug |
| Proprietary Name | PainZone |
| Generic Name | External Analgesic |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2016-07-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Labeler Name | MedZone Products LLC |
| Substance Name | CAMPHOR, (-)-; MENTHOL; METHYL SALICYLATE |
| Active Ingredient Strength | 30 mg/g; mg/g; mg/g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 70338-641-10
28 g in 1 BOTTLE, WITH APPLICATOR (70338-641-10)
| Marketing Start Date | 2016-09-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70338-641-30 [70338064130]
PainZone CREAM
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-09-30 |
NDC 70338-641-12 [70338064112]
PainZone CREAM
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-07-01 |
NDC 70338-641-10 [70338064110]
PainZone CREAM
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-09-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CAMPHOR, (-)- | 30 mg/g |
OpenFDA Data
| SPL SET ID: | 3773fe01-2206-206c-e054-00144ff88e88 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "PainZone" or generic name "External Analgesic"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70338-641 | PainZone | External Analgesic |
| 82714-001 | BlueStop Max | External Analgesic |
| 65112-261 | Hielo Mineral | External Analgesic |
| 65112-265 | Wakaya RuRu Topical Analgesic | External Analgesic |
Trademark Results [PainZone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PAINZONE 78057353 2670367 Live/Registered |
MEDZONE PRODUCTS, LLC 2001-04-09 |
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