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NDC 36800-0506-02 TopCare 20; 1 mg/g; mg/g Details
TopCare 20; 1 mg/g; mg/g
TopCare is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 36800-0506-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 36800-0506 |
|---|---|
| Product ID | 36800-506_5dabe2dc-3001-4e1d-ba35-3254157ab513 |
| Associated GPIs | 90209902083735 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | TopCare |
| Proprietary Name Suffix | Anti-Itch |
| Non-Proprietary Name | Diphenhydramine Hydrochloride and Zinc Acetate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 20; 1 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0506-02 (36800050602)
| NDC Package Code | 36800-506-02 |
|---|---|
| Billing NDC | 36800050602 |
| Package | 1 TUBE in 1 CARTON (36800-506-02) / 28.4 g in 1 TUBE |
| Marketing Start Date | 2005-09-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7e824774-fec6-4ef9-8d0a-7907f3b7b886 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
| TOPCARE
ANTI-ITCH
diphenhydramine hydrochloride and zinc acetate cream |
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| Labeler - Topco Associates LLC (006935977) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(36800-506) | |