Label: LIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE- lidocaine hcl and hydrocortisone acetate gel

  • NDC Code(s): 59088-817-01, 59088-817-07
  • Packager: PureTek Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 9, 2025

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  • DESCRIPTION:
    Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the ...
  • INACTIVE INGREDIENTS:
    ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, CITRIC ACID, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PEG-4, PROPYLENE GLYCOL, PROPYLPARABEN, PURIFIED WATER.
  • CLINICAL PHARMACOLOGY:
    MECHANISM OF ACTION: Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting ...
  • INDICATIONS:
    Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal ...
  • CONTRAINDICATIONS:
    Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine ...
  • PRECAUTIONS:
    For external use only.Not for ophthalmic use.Product and used applicators could harm small children if chewed or swallowed. Keep out of reach of children. Topical formulations of ...
  • PRECAUTIONS:
    If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. If extensive areas are treated, the possibility of systemic absorption exists. Systemic ...
  • CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:
    Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone ...
  • USE IN PREGNANCY:
    Teratogenic Effects: Pregnancy Category C Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the ...
  • NURSING MOTHERS:
    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.
  • PEDIATRIC USE:
    Safety and efficacy in children have not been established.
  • ADVERSE REACTIONS:
    During or immediately following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the ...
  • DOSAGE AND ADMINISTRATION:
    Apply product to the affected area(s) twice daily or as directed by a physician. Product should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition ...
  • HOW SUPPLIED:
    PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe contains one (1) Multi-use 100g tube and 15 single-use applicators. NDC 59088-817-01.
  • KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
    Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Protect from freezing.
  • Tube (100 g)
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  • Carton
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  • INGREDIENTS AND APPEARANCE
    Product Information