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NDC 75834-0170-15 NIVAGEN ZINC OXIDE 200 mg/g Details
NIVAGEN ZINC OXIDE 200 mg/g
NIVAGEN ZINC OXIDE is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is ZINC OXIDE.
Product Information
| NDC | 75834-0170 |
|---|---|
| Product ID | 75834-170_c0fffe6a-f964-4a71-aac8-ca5d675e2168 |
| Associated GPIs | 90971020004210 |
| GCN Sequence Number | 005576 |
| GCN Sequence Number Description | zinc oxide OINT. (G) 20 % TOPICAL |
| HIC3 | L3A |
| HIC3 Description | PROTECTIVES |
| GCN | 22080 |
| HICL Sequence Number | 002361 |
| HICL Sequence Number Description | ZINC OXIDE |
| Brand/Generic | Generic |
| Proprietary Name | NIVAGEN ZINC OXIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ZINC OXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/g |
| Substance Name | ZINC OXIDE |
| Labeler Name | Nivagen Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part347 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 75834-0170-15 (75834017015)
| NDC Package Code | 75834-170-15 |
|---|---|
| Billing NDC | 75834017015 |
| Package | 425 g in 1 JAR (75834-170-15) |
| Marketing Start Date | 2018-05-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7b42655b-2163-4637-9f5d-1d2efa1bdf1d Details
SPL UNCLASSIFIED SECTION
WARNINGS
SPL UNCLASSIFIED SECTION
DIRECTIONS
■ For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
■ For poison ivy, oak, and sumac: Apply as needed.
INACTIVE INGREDIENTS
INGREDIENTS AND APPEARANCE
| NIVAGEN ZINC OXIDE
zinc oxide ointment |
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| Labeler - Nivagen Pharmaceuticals, Inc. (052032418) |
Revised: 2/2022
Document Id: c0fffe6a-f964-4a71-aac8-ca5d675e2168
Set id: 7b42655b-2163-4637-9f5d-1d2efa1bdf1d
Version: 5
Effective Time: 20220214