Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DermacinRx Therazole Pak | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ZINC OXIDE | PureTek Corporation | c47f8a9c-9c86-4068-814e-05ab2090d19e | 2024-12-13 | Warnings, Adverse reactions |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center right away.
5 WARNINGS AND PRECAUTIONS Clotrimazole and betamethasone dipropionate cream can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment. Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended. ( 5.2 ) 5.1 Effects on Endocrine System Clotrimazole and betamethasone dipropionate cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Cushing’s syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age. Because of the potential for systemic corticosteroid effects, patients may need to be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a small trial, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days (twice a day) to the crural area of normal adult subjects. Three of the 8 normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal cosyntropin test. The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing [see Use in Specific Populations (8.4) ]. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Pediatric patients may be more susceptible t...
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6 ADVERSE REACTIONS Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency less than 1% included rash, edema, and secondary infection. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product). Adverse reactions reported with the use of clotrimazole are: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.
| Field | Values |
|---|---|
| Rxcui | 308714, 416684 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0472-0379-15 | DermacinRx Therazole Pak | 15 g in 1 TUBE | CREAM | 15 g | 10 mg in 1g | 5 |
| 0472-0379-15 | DermacinRx Therazole Pak | 1 in 1 CARTON | CREAM | 10 mg in 1g | 5 | |
| 59088-563-01 | DermacinRx Therazole Pak | 4 g in 1 PACKET | PASTE | 120 g | 200 mg in 1g | 5 |
| 59088-893-00 | DermacinRx Therazole Pak | 1 in 1 CARTON | KIT | 1 | 5 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59088-893-00 | GM - Gram | 59088-893 | 7fc5e147-b81b-4230-b8af-61d5d294f104 | 1 | 2016-10-06 |
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308714 | clotrimazole 1 % / betamethasone 0.05 % Topical Cream | PSN | c47f8a9c-9c86-4068-814e-05ab2090d19e | 5 |
| 416684 | zinc oxide 20 % Topical Paste | PSN | c47f8a9c-9c86-4068-814e-05ab2090d19e | 5 |
| 308714 | betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream | SCD | c47f8a9c-9c86-4068-814e-05ab2090d19e | 5 |
| 416684 | zinc oxide 0.2 MG/MG Paste | SCD | c47f8a9c-9c86-4068-814e-05ab2090d19e | 5 |
| 308714 | betamethasone 0.05 % / clotrimazole 1 % Topical Cream | SY | c47f8a9c-9c86-4068-814e-05ab2090d19e | 5 |
| 308714 | betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream | SY | c47f8a9c-9c86-4068-814e-05ab2090d19e | 5 |
| 416684 | zinc oxide 20 % Topical Paste | SY | c47f8a9c-9c86-4068-814e-05ab2090d19e | 5 |
| 416684 | ZNO 0.2 MG/MG Paste | SY | c47f8a9c-9c86-4068-814e-05ab2090d19e | 5 |
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0472-0379-15 | 00472037915 | 15 g in 1 TUBE | 15 g | Historical | ||||
| 59088-563-01 | 59088056301 | 4 g in 1 PACKET | 4 g | Historical | ||||
| 59088-893-00 | 59088089300 | 1 KIT in 1 CARTON (59088-893-00) * 1 TUBE in 1 CARTON (0472-0379-15) / 15 g in 1 TUBE * 4 g in 1 PACKET (59088-563-01) | 1 kit | 2016-08-09 | 0000-00-00 | No | No | Current |