NDC 76441-909 Lice-nil Lice And Eggs Eliminator Oil

Azadirachta Indica

NDC Product Code 76441-909

NDC 76441-909-94

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Lice-nil Lice And Eggs Eliminator Oil with NDC 76441-909 is a a human over the counter drug product labeled by Sujanil Chemo Industries. The generic name of Lice-nil Lice And Eggs Eliminator Oil is azadirachta indica. The product's dosage form is oil and is administered via topical form.

Labeler Name: Sujanil Chemo Industries

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

Product Type: Human Otc Drug 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.

Lice-nil Lice And Eggs Eliminator Oil Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AZADIRACHTA INDICA SEED OIL 1 [hp_X]/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • COCONUT OIL (UNII: Q9L0O73W7L)
  • SESAME OIL (UNII: QX10HYY4QV)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
  • LEMON OIL (UNII: I9GRO824LL)
  • ROSEMARY OIL (UNII: 8LGU7VM393)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sujanil Chemo Industries
Labeler Code: 76441
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 08-01-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Lice-nil Lice And Eggs Eliminator Oil Product Label Images

Lice-nil Lice And Eggs Eliminator Oil Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Azadirachta Indica (NEEM) 1X

Purpose

Lice treatment.

Uses:

Treats head lice/nits, pubic lice (crab) and body lice

Warnings

  • For External Use OnlyDo not use:Near eyesInside nose, mouth or vaginaOn lice in eyebrows or eyelashes. See a doctor if lice are present in these areasAsk a Doctor before use if you are:Allergic to ragweed. May cause breathing difficulty or an asthmatic attackWhen using this product:If product gets in eyes, flush with water right awayStop use and ask a doctor if:Breathing difficulty occursEye irritation occursSkin or scalp irritation or infection occurs

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right awayImportant: Read warnings before useFor Adults and Children 2 years and older

Directions

  • InspectCheck each household member with a magnifying glass in bright light for lice/nits (eggs)Look for tiny nits near scalp, beginning at back of neck and behind earsExamine small sections of hair at a timeUnlike dandruff which moves when touched, nits stick to the roots of hairIf either lice or nits are found, treat with this productTreatApply thoroughly to dry hair or other affected area. For head lice, first apply on hair behind ears and back of neck, then continue to apply to the remainder of hairLeave product on hair for a minimum of 20 minutesWash area thoroughly with warm water and shampoo or soap after treatmentFor head lice, towel dry hair and comb out tanglesRemove lice and their eggs (nits)Using a fine-tooth comb or special lice/nit comb, remove any remaining nits by hand.For head lice, part hair into sections and inspect one section at a time, starting at the top of head. Longer hair may take 1-2 hours.Lift a 1-2-inch wide strand of hair. Place comb with a firm, even motion away from scalp.Pin back each strand of hair after combingClean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming backAfter combing, thoroughly recheck for lice/nits. Repeat combing if necessaryCheck daily for any lice/nits that may have been missedWe recommend a second treatment after 7-10 days to kill any newly hatched liceChildren under 2 years: Consult with a Doctor or Physician

Other Information

  • Shake well before useStore in cool and dry placeKeep carton for important product informationSee package insert for additional information

Inactive Ingredients:

Coconut Oil, Sesame Oil, Tea Tree Oil, Sunflower Oil with Herbal Extracts and Perfumes

* Please review the disclaimer below.