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Hydroxym

Hydroxym Gel

Approved
Approval ID

febffc84-e65e-e811-e053-6294a90a0ad1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 12, 2023

Manufacturers
FDA

PureTek Corporation

DUNS: 785961046

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

HYDROCORTISONE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59088-209
Product Classification
G
Generic Name
HYDROCORTISONE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 12, 2023
FDA Product Classification

INGREDIENTS (8)

HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 200Inactive
Code: R95B8J264J
Classification: IACT
HYDROCORTISONEActive
Quantity: 2 g in 100 g
Code: WI4X0X7BPJ
Classification: ACTIB
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 6/22/2023

DESCRIPTION

Each gram of Hydroxym Gel contains 20 mg of hydrocortisone. Inactive ingredients include: Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Hydroxyethyl Cellulose, Methylparaben, PEG-4, Propylene Glycol,Propylparaben.

Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-] with the molecular formula (C 21H 30O 5) and is represented by the following structural formula:

Structure

Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 6/22/2023

HOW SUPPLIED:

Hydroxym™ Gel is available as follows:
1 oz. (28 g) tube (NDC 59088-209-03)

Do not use if tube seal is broken.
** KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.**
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

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Hydroxym - FDA Drug Approval Details