Topical corticosteroids are contraindicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
For external use only. Not for ophthalmic use.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 1-877-921-7873
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59088-209-03 | GM - Gram | 59088-209 | c37d96bc-10f6-403f-9186-fe34ceb70750 | 1 | 2023-08-08 |
| Product NDC | Package NDC |
|---|---|
| 59088-209 | 59088-209-03 |
| Name | UNII | Kind |
|---|---|---|
| HYDROXYETHYL CELLULOSE, UNSPECIFIED | T4V6TWG28D | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 200 | R95B8J264J | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
Rx only
ACTIVE INGREDIENT : HYDROCORTISONE 2% INACTIVE INGREDIENTS : Aloe Barbadensis (Aloe Vera) Leaf Juice, 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 21 H 30 O 5 ) and is represented by the following structural formula: Its molecular weight is 362.46 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.
Mechanism of Action Topical corticosteroids share anti-inflammatory, antipruritic, and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Topical corticosteroids are contraindicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
For external use only. Not for ophthalmic use.
The following local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Hydroxym™ Gel is available as follows: 1 oz. (28 g) tube (NDC 59088-209-03)
Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 1-877-921-7873
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2023-07-12 | full-release | 2026-05-31 20:51:24 |