Smart Sense Allergy Relief Non Drowsy label

Smart Sense Allergy Relief Non Drowsy

Smart Sense Allergy Relief Non Drowsy Recall

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Uses

Locoid® Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

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History

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Other Information

Locoid® (hydrocortisone butyrate) Lotion, 0.1% contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester, for topical use. The chemical name of hydrocortisone butyrate is 11ß,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate. It has the following structural formula:

hydrocortisone butyrate structure

Hydrocortisone butyrate is a white to off white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform.

Each gram of Locoid® Lotion contains 1 mg of hydrocortisone butyrate in a white to off white lotion base consisting of anhydrous citric acid, ceteth-20, cetostearyl alcohol, butylated hydroxytoluene (BHT), butylparaben, light mineral oil, propylparaben, purified water, safflower oil, sodium citrate, and white petrolatum.

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Smart Sense Allergy Relief Non Drowsy Recall
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Smart Sense Allergy Relief Non Drowsy Manufacturers

  • Kmart Corporation
    Smart Sense Allergy Relief Non Drowsy | Onset Dermatologics, Llc
    No Recall

    Smart Sense Allergy Relief Non Drowsy | Onset Dermatologics, Llc

    Smart Sense Allergy Relief Non Drowsy | Onset Dermatologics, Llc

    Apply a thin layer to the affected skin areas two times daily, and rub in gently. Do not apply Locoid® Lotion in the diaper area unless directed by a physician.

    Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of Locoid® Lotion has not been established beyond 4 weeks of use [see Warnings and Precautions (5.1)].

    Do not use Locoid® Lotion with occlusive dressings unless directed by a physician. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

    Locoid® Lotion is not for oral, ophthalmic, or intravaginal use.

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