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NDC 36800-0471-64 Topcare Hydrocortisone 1 g/100g Details
Topcare Hydrocortisone 1 g/100g
Topcare Hydrocortisone is a TOPICAL OINTMENT 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: 36800-0471-64Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 36800-0471 |
|---|---|
| Product ID | 36800-471_ee1ecf2b-0153-40dd-ac05-7f3507eb2d85 |
| 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 Hydrocortisone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | hydrocortisone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| 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 36800-0471-64 (36800047164)
| NDC Package Code | 36800-471-64 |
|---|---|
| Billing NDC | 36800047164 |
| Package | 1 TUBE in 1 CARTON (36800-471-64) / 28 g in 1 TUBE |
| Marketing Start Date | 2020-04-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 849c60fc-e455-4c50-8adf-ac59c0ee785b Details
Uses
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- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
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- eczema
- •
- psoriasis
- •
- poison ivy, oak, sumac
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- insect bites
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- detergents
- •
- jewelry
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- cosmetics
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- soaps
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- seborrheic dermatitis
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- temporarily relieves external anal and genital itching
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- other uses of this product should only be under the advice and supervision of a doctor
Warnings
For external use only
Do not use
- •
- for the treatment of diaper rash. Ask a doctor.
- •
- in the genital area if you have a vaginal discharge. Ask a doctor.
When using this product
- •
- avoid contact with the eyes
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- do not use more than directed unless told to do so by a doctor
- •
- do not put directly into the rectum by using fingers or any mechanical device or applicator
Directions
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- for itching of skin irritation, inflammation, and rashes:
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- 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, ask a doctor
- •
- for external anal and genital itching, adults:
- •
- when practical, clean 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 applying
- •
- apply to affected area not more than 3 to 4 times daily
- •
- children under 12 years of age: ask a doctor
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| TOPCARE HYDROCORTISONE
hydrocortisone ointment |
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| Labeler - Topco Associates LLC (006935977) |
Revised: 2/2022
Document Id: ee1ecf2b-0153-40dd-ac05-7f3507eb2d85
Set id: 849c60fc-e455-4c50-8adf-ac59c0ee785b
Version: 3
Effective Time: 20220225