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NDC 37808-0369-64 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 H E B. 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: 37808-0369-64Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 37808-0369 |
|---|---|
| Product ID | 37808-369_08498129-7eab-451d-a88a-786d4a8f62a0 |
| 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 | hydrocortisone |
| Proprietary Name Suffix | anti itch |
| 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 | H E B |
| 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 37808-0369-64 (37808036964)
| NDC Package Code | 37808-369-64 |
|---|---|
| Billing NDC | 37808036964 |
| Package | 1 TUBE in 1 CARTON (37808-369-64) / 28 g in 1 TUBE |
| Marketing Start Date | 2010-09-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a1a9fed8-4938-48b5-81f1-d3942d534bb8 Details
Uses
- •
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- •
- eczema
- •
- psoriasis
- •
- poison ivy, oak, sumac
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- insect bites
- •
- detergents
- •
- jewelry
- •
- cosmetics
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- soaps
- •
- seborrheic dermatitis
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- temporarily relieves external anal and genital itching
- •
- 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
- •
- 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
- •
- for itching of skin irritation, inflammation, and rashes:
- •
- 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
Inactive ingredients
aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate
Principal Display Panel
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE
ANTI ITCH
hydrocortisone cream |
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| Labeler - H E B (007924756) |
Revised: 12/2019
Document Id: 08498129-7eab-451d-a88a-786d4a8f62a0
Set id: a1a9fed8-4938-48b5-81f1-d3942d534bb8
Version: 4
Effective Time: 20191205