Pure Kleen is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Chemject International, Inc.. The primary component is Alcohol.
| Product ID | 75455-002_a3c106c6-f83b-a468-e053-2a95a90ac57a |
| NDC | 75455-002 |
| Product Type | Human Otc Drug |
| Proprietary Name | Pure Kleen |
| Generic Name | Ethanol, 80% |
| Dosage Form | Liquid |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2020-04-20 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part333A |
| Labeler Name | Chemject International, Inc. |
| Substance Name | ALCOHOL |
| Active Ingredient Strength | 80 mL/100mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-04-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph not final |
| Application Number | part333A |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-04-20 |
| Marketing Category | OTC monograph not final |
| Application Number | part333A |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-04-20 |
| Marketing Category | OTC monograph not final |
| Application Number | part333A |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-04-20 |
| Marketing Category | OTC monograph not final |
| Application Number | part333A |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-04-20 |
| Marketing Category | OTC monograph not final |
| Application Number | part333A |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-04-20 |
| Ingredient | Strength |
|---|---|
| ALCOHOL | 80 mL/100mL |
| SPL SET ID: | a3c10fb4-37c1-41fb-e053-2995a90a9612 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 75455-001 | Pure Kleen | Isopropyl Alcohol, 75% |
| 75455-002 | Pure Kleen | Ethanol, 80% |
| 76016-544 | Pure Kleen | CHLOROXYLENOL |
| 75455-004 | Jet Kleen HS E-80 | Ethanol, 80% |