Search by Drug Name or NDC
NDC 24338-0185-04 Sklice 5 mg/g Details
Sklice 5 mg/g
Sklice is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Azurity Pharmaceuticals. The primary component is IVERMECTIN.
MedlinePlus Drug Summary
Ivermectin lotion is used to treat head lice (small bugs that attach themselves to the skin) in adults and children 6 months of age and older. Ivermectin is in a class of medications called anthelmintics. It works by killing lice.
Related Packages: 24338-0185-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ivermectin Topical
Product Information
| NDC | 24338-0185 |
|---|---|
| Product ID | 24338-185_109a8515-714e-4fa5-9995-fc8f6c34b64e |
| Associated GPIs | |
| GCN Sequence Number | 068579 |
| GCN Sequence Number Description | ivermectin LOTION 0.5 % TOPICAL |
| HIC3 | Q5R |
| HIC3 Description | TOPICAL ANTIPARASITICS |
| GCN | 31394 |
| HICL Sequence Number | 010933 |
| HICL Sequence Number Description | IVERMECTIN |
| Brand/Generic | Brand |
| Proprietary Name | Sklice |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ivermectin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/g |
| Substance Name | IVERMECTIN |
| Labeler Name | Azurity Pharmaceuticals |
| Pharmaceutical Class | Antiparasitic [EPC], Pediculicide [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA202736 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 24338-0185-04 (24338018504)
| NDC Package Code | 24338-185-04 |
|---|---|
| Billing NDC | 24338018504 |
| Package | 1 TUBE in 1 CARTON (24338-185-04) / 117 g in 1 TUBE |
| Marketing Start Date | 2022-08-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7579bdfe-a538-4bff-b7c7-df2c4b6f13db Details
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
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 your hair
- use only amount 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.
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 117 g Tube Carton
INGREDIENTS AND APPEARANCE
| SKLICE
ivermectin lotion |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Azurity Pharmaceuticals (117505635) |
Revised: 9/2022
Document Id: 109a8515-714e-4fa5-9995-fc8f6c34b64e
Set id: 7579bdfe-a538-4bff-b7c7-df2c4b6f13db
Version: 5
Effective Time: 20220909