Triamcinolone Acetonide Lotion
FDA Label NDC 70752-129

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quagen Pharmaceuticals Llc for the product Triamcinolone Acetonide (NDC 70752-129). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, adverse reactions, overdosage, dosage and administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Triamcinolone Acetonide Lotion, USP is supplied in the following strengths: 0.025%, 0.1%. Each mL of Triamcinolone Acetonide Lotion, USP, 0.025%, 0.1% contains 0.25 mg, 1 mg triamcinolone acetonide, USP in a lotion base containing citric acid, cetyl alcohol, dimethicone, polysorbate 20, propylene glycol, purified water, sorbitan monopalmitate, and stearyl alcohol. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment.

Triamcinolone Acetonide is a topical corticosteroid known chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone.

The molecular formula is C24H31FO6. It has the following structure:

Image Description (Chemsture)

Image Description (Chemsture)

Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic 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.

Indications And Usage

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

The following local adverse reactions are 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 Perioral dermatitis
 Itching Allergic contact dermatitis
 Irritation Maceration of the skin
 Dryness Secondary infection
 Folliculitis Skin Atrophy
 Hypertrichosis Striae
 Acneiform eruptions Miliaria
 Hypopigmentation

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Dosage And Administration

Topical corticosteroids are generally applied to the affected area as a thin film from three 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.

How Supplied

Triamcinolone Acetonide Lotion, USP 0.025% is supplied in the following size: 60 mL. (NDC 70752-129-05).

Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL. (NDC 70752-130-05).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

AVOID FREEZING

SHAKE WELL BEFORE USING

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