Diabecin HR Lidocaine HCl, Benzalkonium Chloride 50 mg/g; 41.2 mg/g; 1.3 mg/g Cream, 57 g
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Diabecin HR is a topical cream containing lidocaine hydrochloride, benzalkonium chloride, and dimethicone. Lidocaine is a local anesthetic typically used to numb skin and reduce discomfort in topical products. Benzalkonium chloride functions as an antimicrobial preservative and cleansing agent commonly found in skin care preparations. Dimethicone is a silicone-based ingredient often included to help protect and condition the skin. This product is marketed without an approved FDA application.
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII WR1WPI7EW8
A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
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UNII Q9HR0J0H4B
This is a modified sugar derivative containing silicon that acts as a binder and thickening agent in medicines. It helps hold tablet ingredients together and adds texture to formulations.
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Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
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UNII OZ0E5Y15PZ
A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
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UNII K49155WL9Y
Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
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A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
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UNII 0A5MM307FC
A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
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UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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UNII FGL3685T2X
Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
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UNII 0THT5PCI0R
A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
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Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
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UNII YD01N1999R
A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
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UNII 86P27YRR6Y
A plant extract from peucedanum ostruthium leaves used as a natural flavoring or aromatic ingredient in medicines. It may help provide taste or scent to make the medication more palatable.
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Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
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UNII 5D6TC4BRWV
Polyacrylamide is a synthetic polymer used as a thickener and stabilizer in medicines. It helps maintain consistent texture and prevents separation of ingredients in liquid or semi-solid formulations.
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A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
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UNII 632GS99618
Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII 9LBV3F07AZ
A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
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Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
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UNII RDS2V6DVY5
A plant extract from grape seeds that contains natural compounds. Used in supplements and medicines as an antioxidant ingredient and to support product stability.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
28 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diabecin HR 50 mg/g; 41.2 mg/g; 1.3 mg/gthis 59088-0790-05 | PureTek | 57 g | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59088-0790-05 You're viewing this | 57 g in 1 TUBE (59088-790-05) | 2025-06-10 | Active |
🧭 About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS: Diabecin HR™ Cream is indicated for the temporary relief of pain and itching associated with minor skin irritations. It combines the anesthetic properties of Lidocaine, and the antiseptic effects of Benzalkonium Chloride to provide effective care for damaged skin.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Apply to the affected area of the heel two or three times daily or as directed by a licensed healthcare practitioner. Use under the direction of a licensed healthcare practitioner.
⛔ Contraindications ▾
CONTRAINDICATIONS: Tuberculosis or fungal lesions of the skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
⚠️ Warnings and Cautions ▾
WARNINGS: For external use only. Not for ophthalmic use. EXCESSIVE DOSING: Excessive dosing by applying Diabecin HR™ Cream to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions).
Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine.
With recommended dosing, the average peak blood concentration is about 0.13 mcg/ mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Application Site Reactions Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. It is advisable to apply a small amount on the forearm prior to first use. If any of these effects persist or worsen, contact your physician or pharmacist immediately.
Systemic absorption of this medication is expected to be minimal when used as directed. However, if serious side effects occur (e.g., rash, swelling, severe dizziness), discontinue use and consult your pharmacist or physician. This is not a complete list of all possible side effects.
You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch. Allergic Reactions: Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria.
If they occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Other Adverse Events: Due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor.
Systemic (Dose-Related) Reactions: Systemic adverse reactions following appropriate use of lidocaine is unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest).
Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest. To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800- 272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.
🔄 Drug Interactions ▾
Drug Interactions Antiarrhythmic Drugs: Diabecin HR™ Cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Diabecin HR™ Cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects: Pregnancy Category B. Lidocaine has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine.
There are, however, no adequate and well- controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine should be used during pregnancy only if clearly needed. Labor and Delivery: Lidocaine has not been studied in labor and delivery.
Lidocaine is not contraindicated in labor and delivery. Should lidocaine be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered. Nursing Mothers: Lidocaine has not been studied in nursing mothers.
Lidocaine is excreted in human milk, and the milk: plasma ratio of lidocaine is 0.4. Caution should be exercised when lidocaine is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE: Lidocaine overdose from cutaneous absorption is rare but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions), drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment.
Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or over dosage from other sources of lidocaine or other local anesthetics. The oral LD50 of lidocaine HCl is 459 (346 to 773) mg/kg (as the salt) in non-fasted female rats and 214 (159 to 324) mg/kg (as the salt) in fasted female rats, which are equivalent to roughly 4000 mg and 2000 mg, respectively, in a 60 to 70 kg man based on the equivalent surface area dosage conversion factors between species.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Pharmacodynamics Lidocaine- is a common local anesthetic that relieves itching, burning, and pain. Topically, it blocks both initiation and conduction or nerve impulses by decreasing ionic flux through the neuronal membrane. Since it penetrates the skin, it creates an anesthetic effect by not just preventing pain signals from propagating to the brain out by stopping them before they begin.
Benzalkonium Chloride serves as an antiseptic, preventing infection in minor skin injuries. Pharmacokinetics Absorption: Lidocaine- Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration and total dosage. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration.
Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation in the liver. Lidocaine is metabolized rapidly by the liver and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage and conjugation.
N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/ toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites and less than 10% is excreted unchanged.
The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The plasma binding of lidocaine is dependent on drug concentration and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 g of free base per mL, 60 to 80 percent of lidocaine is protein bound.
Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours.
Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.
Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 g free base per mL. In the rhesus monkey, arterial blood levels of 18-21 g/mL have been shown to be threshold for convulsive activity.
Benzalkonium Chloride acts locally with minimal systemic absorption. Excretion: Lidocaine- Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of Lidocaine is excreted unchanged.
The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15). The systemic clearance is 0.33 to
0.90L/min (mean 0.64 ±
0.18SD, n = 15). Benzalkonium chloride, a quaternary ammonium compound, is also minimally absorbed through the skin when applied topically. If some systemic absorption occurs, benzalkonium chloride is metabolized in the liver and the metabolites are primarily excreted via the kidneys into the urine. The small amount absorbed is eliminated relatively quickly, reducing the potential for systemic toxicity.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Diabecin HR™ Cream is supplied in a 2 oz (57 g) tube (NDC 59088-790-05). CAUTION: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
📋 Description ▾
Full Prescribing Information: Description: Diabecin HR™ Cream contains 41.2 mg of Lidocaine HCl per gram, and 1.3 mg of Benzalkonium Chloride per gram in a vehicle of Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Arnica Montana Flower Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Carbomer, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cyclopentasiloxane, Dimethicone, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Methylsilanol Mannuronate, Panthenol, PEG-100 Stearate, Peucedanum Ostruthium (Masterwort) Leaf Extract, Phenoxyethanol, Propylene Glycol, Retinyl Palmitate, Sodium Lauroyl Sarcosinate, Stearic Acid, Tetrahexyldecyl Ascorbate, Triethanolamine, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum, Zea Mays (Corn) Starch.