Ivermectin Lotion
NDC 88060-001
Ivermectin .5 g/100g · Lotion (topical)
Product Information
This code was recently added to the official NDC directory and the product has entered commercial distribution.
Ivermectin is a ANDA-approved product labeled by Whitezenith Inc. This medication is typically used as a antiparasitic [epc]. It is supplied as a lotion for topical administration. This product entry covers the primary NDC 88060-001 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
88060-001
Proprietary Name:
Ivermectin
Non-Proprietary Name: [1]
Ivermectin
Substance Name: [2]
Ivermectin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications
Dosage Form:
Lotion
- An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
88060
Product Label ID:
FDA Application Number: [6]
ANDA210720
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
10-18-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 88060-001?
The NDC code 88060-001 is assigned by the FDA to the product Ivermectin. This pharmaceutical product is labeled by Whitezenith Inc and is currently categorized as listed product. The medication is a lotion administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 88060-001-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Important: Read warnings before usechildren 6 months of age to under 12 years of age: an adult should supervise use
adults and children 6 months of age and over:
Inspectall 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
Treatyour 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 your 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 rinseallow 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 treatmentwash 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.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- IVERMECTIN .5 g/100g - A mixture of mostly avermectin H2B1a (RN 71827-03-7) with some avermectin H2B1b (RN 70209-81-3), which are macrolides from STREPTOMYCES avermitilis. It binds glutamate-gated chloride channel to cause increased permeability and hyperpolarization of nerve and muscle cells. It also interacts with other CHLORIDE CHANNELS. It is a broad spectrum antiparasitic that is active against microfilariae of ONCHOCERCA VOLVULUS but not the adult form.
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? 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.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
