Sklice Lotion
FDA Label NDC 24338-185

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Azurity Pharmaceuticals for the product Sklice (NDC 24338-185). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, do not use, ask a doctor before use if you, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 117 G Tube Carton

Other

Drug Facts

Distributed by:
arbor^®
PHARMACEUTICALS, LLC
Atlanta, GA 30328

Manufactured by:
Jubilant HollisterStier
General Partnership
16751 Trans-Canada Highway
Kirkland, Quebec,
Canada H9H 4J4

Active Ingredient

Ivermectin 0.5%

Purpose

Lice treatment

Use

treats head lice

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

store at room temperature 68°-77°F. Excursions permitted to 59°-86°F.
do not freeze
keep carton and see Consumer Information Leaflet and warnings before use

Inactive Ingredients

acetylated lanolin alcohol, cetyl acetate, citric acid, cyclomethicone, lanolin alcohol, methylparaben, oleyl alcohol, olive oil, polysorbate 80, propylparaben, shea butter, sodium citrate, sorbitan tristearate, and water