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NDC 69396-0069-09 Hydrocortisone 1% 1 g/100g Details
Hydrocortisone 1% 1 g/100g
Hydrocortisone 1% is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Trifecta Pharmaceuticals Usa 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: 69396-0069-09Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
NDC | 69396-0069 |
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Product ID | 69396-069_d57ac9a8-a157-7724-e053-2a95a90a235f |
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 1% |
Proprietary Name Suffix | n/a |
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 | Trifecta Pharmaceuticals Usa 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 | 2023-12-31 |
Package
Package Images

NDC 69396-0069-09 (69396006909)
NDC Package Code | 69396-069-09 |
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Billing NDC | 69396006909 |
Package | 144 PACKET in 1 CARTON (69396-069-09) / .9 g in 1 PACKET |
Marketing Start Date | 2020-11-24 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b478c1c7-6fb8-4a55-e053-2a95a90a360a Details
SPL UNCLASSIFIED SECTION
Uses
Do Not Use
When using this product
Stop using this product and ask a doctor if
Directions
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use and ask a doctor.
For External and anal itching in adults:
When practical, clean 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
For External anal and genital itching in children under 12 years of age:
Ask a doctor
Inactive ingredients
Other information
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
HYDROCORTISONE 1%
hydrocortisone cream |
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Labeler - Trifecta Pharmaceuticals Usa Llc (079424163) |