Ivermectin
Taro Pharmaceuticals U.s.a., Inc.
Human Otc Drug
NDC 51672-4230Ivermectin is a human otc drug labeled by 'Taro Pharmaceuticals U.s.a., Inc.'. National Drug Code (NDC) number for Ivermectin is 51672-4230. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Ivermectin drug includes Ivermectin - 5 mg/g . The currest status of Ivermectin drug is Active.
Drug Information:
| Drug NDC: | 51672-4230 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ivermectin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Ivermectin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Taro Pharmaceuticals U.s.a., Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | IVERMECTIN - 5 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 06 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA210720 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Taro Pharmaceuticals U.S.A., Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1246673
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175484
N0000181811
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 8883YP2R6D
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Antiparasitic [EPC]
Pediculicide [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Antiparasitic [EPC]
Pediculicide [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51672-4230-8 | 1 TUBE in 1 CARTON (51672-4230-8) / 117 g in 1 TUBE | 06 Jan, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose lice treatment
Product Elements:
Ivermectin ivermectin ivermectin ivermectin butylated hydroxyanisole castor oil cetyl alcohol anhydrous citric acid cyclomethicone glycerin imidurea lanolin alcohols methylparaben oleyl alcohol olive oil propylene glycol propylparaben water shea butter anhydrous trisodium citrate sorbitan tristearate stearyl alcohol off-white;tan
Indications and Usage:
Use treats head lice
Warnings:
Warnings for external use only. use only on the scalp. do not use on children under 6 months of age near the eyes inside the nose, ear, mouth, or vagina on lice in eyebrows or eyelashes. see a doctor if lice are present in these areas. ask a doctor before use if you have any skin conditions or sensitivities are pregnant or plan to become pregnant. it is not known if product can harm your unborn baby. are currently or planning to breastfeed. avoid getting product on your breast to help prevent contact by your baby. when using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, gently flush with water eye redness, soreness, or irritation can occur dandruff, dry skin, or burning sensation of the skin can occur stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs rash develops if pregnant or breastfeeding, ask a health professional before use. keep out of
Read more... reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
Do Not Use:
Warnings for external use only. use only on the scalp. do not use on children under 6 months of age near the eyes inside the nose, ear, mouth, or vagina on lice in eyebrows or eyelashes. see a doctor if lice are present in these areas. ask a doctor before use if you have any skin conditions or sensitivities are pregnant or plan to become pregnant. it is not known if product can harm your unborn baby. are currently or planning to breastfeed. avoid getting product on your breast to help prevent contact by your baby. when using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, gently flush with water eye redness, soreness, or irritation can occur dandruff, dry skin, or burning sensation of the skin can occur stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs rash develops if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, gently flush with water eye redness, soreness, or irritation can occur dandruff, dry skin, or burning sensation of the skin can occur
Dosage and Administration:
Directions important: read warnings before use children 6 months of age to under 12 years of age: an adult should supervise use adults and children 6 months of age and over: inspect all household members should be checked by another person for lice and/or nits (eggs) use a magnifying glass in bright light to help you see the lice and/or nits (eggs) use a tool, such as a comb or two unsharpened pencils to lift and part the hair look for tiny nits near the scalp, beginning at the back of the neck and behind the ears examine small sections of the hair (1-2 inches wide) at a time unlike dandruff, nits stick to the hair. dandruff should move when lightly touched. if either lice or nits (eggs) are found, treat with product treat your hair and scalp must be dry before applying product use the top of cap to break the tamper seal on the tube apply product directly to dry hair and scalp completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of y
Read more...our hair use only amount needed to completely cover hair and scalp, up to 1 entire tube, and discard the remaining rub product throughout your hair it is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. be sure that each hair is coated from the scalp to the tip. wait and rinse allow product to stay on your hair and scalp for 10 minutes after it has been applied. use a timer or clock. start timing after you have completely covered your hair and scalp with product. after 10 minutes, rinse product completely from your hair and scalp using only water after rinsing, dry and style as usual. wait 24 hours before applying shampoo. after treatment wash your hands after applying product nit combing is not necessary when treating with product for it to work, but if desired, a fine-tooth comb or special nit comb may be used to remove dead lice and nits this is a single use product. discard tube after use. do not use again on the same person and same lice infestation without talking to a healthcare provider first if infestation continues, see a doctor for other treatments machine wash any bedding and clothing used by anyone having lice. machine wash at high temperatures (150°f) and tumble in a hot dryer for 20 minutes. after finishing treatment with lice medicine, check everyone in your family for lice after one week. consider treatment for those who have lice.
Stop Use:
Stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs rash develops
Package Label Principal Display Panel:
Principal display panel - 117 g tube carton compare to the active ingredient in sklice ® ndc 51672-4230-8 ivermectin lotion, 0.5% lice treatment original prescription strength now available without a prescription! one tube, one time, 10 minutes! ivermectin lotion kills lice no nit combing required no second application required includes: 1 tube net wt. 4 oz (117 g) principal display panel - 117 g tube carton
Further Questions:
Questions? 1-866-923-4914