Search by Drug Name or NDC
NDC 36800-0059-02 TopCare 1 g/100g Details
TopCare 1 g/100g
TopCare is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is HYDROCORTISONE.
MedlinePlus Drug Summary
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 36800-0059-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 36800-0059 |
|---|---|
| Product ID | 36800-059_09c7ad10-600d-4f02-874a-d610a9d25009 |
| Associated GPIs | |
| 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 | Hydrocortisone 1% with Aloe |
| Non-Proprietary Name | Hydrocortisone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | HYDROCORTISONE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0059-02 (36800005902)
| NDC Package Code | 36800-059-02 |
|---|---|
| Billing NDC | 36800005902 |
| Package | 1 TUBE in 1 CARTON (36800-059-02) / 28.4 g in 1 TUBE |
| Marketing Start Date | 1995-08-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2a235963-4d7a-4f6a-8c02-a0ef4b954585 Details
Uses
- temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external genital and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Do not use
- in the eyes
- by putting this product into the rectum by using fingers or any mechanical device or applicator
Directions
Adults and children 2 years of age and older:
- apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: do not use. consult a doctor
For external anal itching:
- Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
| TOPCARE
HYDROCORTISONE 1% WITH ALOE
hydrocortisone cream |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Topco Associates LLC (006935977) |
| Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Phamaceuticals Inc. | 206263295 | MANUFACTURE(36800-059) | |
Revised: 2/2019
Document Id: 09c7ad10-600d-4f02-874a-d610a9d25009
Set id: 2a235963-4d7a-4f6a-8c02-a0ef4b954585
Version: 2
Effective Time: 20190215