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NDC 51672-2063-02 Hydrocortisone 1 g/100g Details
Hydrocortisone 1 g/100g
Hydrocortisone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. 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: 51672-2063-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
NDC | 51672-2063 |
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Product ID | 51672-2063_9b5c4508-91ad-428d-8704-64aa27579344 |
Associated GPIs | 90550075003720 |
GCN Sequence Number | 007544 |
GCN Sequence Number Description | hydrocortisone CREAM (G) 1 % TOPICAL |
HIC3 | Q5P |
HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
GCN | 30942 |
HICL Sequence Number | 002867 |
HICL Sequence Number Description | HYDROCORTISONE |
Brand/Generic | Generic |
Proprietary Name | Hydrocortisone |
Proprietary Name Suffix | Plus 12 Moisturizers |
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 | Taro Pharmaceuticals U.S.A., Inc. |
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 51672-2063-02 (51672206302)
NDC Package Code | 51672-2063-2 |
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Billing NDC | 51672206302 |
Package | 1 TUBE in 1 CARTON (51672-2063-2) / 28.4 g in 1 TUBE |
Marketing Start Date | 1989-10-03 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.06188 |
Pricing Unit | GM |
Effective Date | 2024-02-21 |
NDC Description | HYDROCORTISONE 1% CREAM |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 1, 5 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 09ac2749-a60f-4039-8c80-a0d2eaf50c34 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
Other information
Inactive ingredients
aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
PLUS 12 MOISTURIZERS
hydrocortisone cream |
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Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(51672-2063) |