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NDC 71241-0002-99 BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH 1 g/100g Details
BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH 1 g/100g
BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Sientra, Inc.. The primary component is HYDROCORTISONE ACETATE.
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: 71241-0002-99Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 71241-0002 |
|---|---|
| Product ID | 71241-002_b8ab3acc-d508-1454-e053-2995a90ad733 |
| 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 | BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydrocortisone acetate 1% |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | HYDROCORTISONE ACETATE |
| Labeler Name | Sientra, 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 | 2023-12-31 |
Package
Package Images
NDC 71241-0002-99 (71241000299)
| NDC Package Code | 71241-002-99 |
|---|---|
| Billing NDC | 71241000299 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (71241-002-99) / 5 g in 1 BOTTLE, PUMP (71241-002-05) |
| Marketing Start Date | 2018-05-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6bb6aa59-65cc-2852-e053-2991aa0a087c Details
Uses
For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, soaps, detergents and cosmetics. Other uses of this product should be only under the advice and supervision of a physician.
Biocorneum can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes,(such as joints).
Directions
Inactive Ingredients
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
For external use only.
Avoid contact with eyes.
Do not use for treatment of diaper rash.
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Keep out of the reach of children.
If swallowed, get medical help or contact a poison control center immediately.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH
hydrocortisone acetate 1% gel |
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| Labeler - Sientra, Inc. (010209877) |