SPL v2
SPL
SPL Set ID 459aafa5-08d4-3667-e063-6294a90a3b94
Route
TOPICAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ivermectin (0.5 g)
Inactive Ingredients
Cetyl Alcohol Stearyl Alcohol Castor Oil Cyclomethicone Butylated Hydroxyanisole Sorbitan Tristearate Sodium Citrate Oleyl Alcohol Propylparaben Water Anhydrous Citric Acid Lanolin Alcohols Olive Oil Glycerin Propylene Glycol Methylparaben Imidurea Shea Butter

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-10

Description

Ivermectin 0.5%


Medication Information

Warnings and Precautions

TAMPER EVIDENT: DO NOT USE IF THEPUMP IS DAMAGED OR SEAL IS BROKEN. Store at room temperature 68℃F-77°

Do not freeze.

keep carton and see Consumer Information Leaflet and warnings before use

Indications and Usage

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 houschold members should be checked by anothe!person for lice and/or nits (eggs)

Use a magnifying glassin bright light to help you see

thelice and/or nits(eggs)

Use a tool, such as a comb or two unsharpened pencilsto lift and part the hair

Look for tiny nits near the scalp, beginning at the backof theneck and behind the ears

Examine small sections ofthe hair (1-2 inches wide) ata time

.Unlike dandruff, nits stick to the hair, Dandruff shouldmove when lightly touched

If either lice or nits (eggs) are found, treat with product

Treat

Your hair and scalp must be DRY before applyingproduct

Apply the product directly onto dry hair and scalp

Completely cover your scalp and hair closest to thescalp first.and then apply outwards towards the endsofyour hair

Use only as much asneeded to fully cover hair andscalp up to one full bottle, and discard the remainingRub product throughout your hair

Itis important to completely cover your entire head sothat all lice and eggs are exposed to the lotion, Be surethat each hair is coated from the scalp to the tip

Wait and Rinse

Allow product to stay on your hair and scalp for 10minutes after it has been applied, Use a timer or clockStart timing after you have completely covered yourhair and scalp with product.

After 10 minutes, rinse product completely from youhair and scalp using only water.

After rinsing, dry and style hair as usual. Wait 24 hoursbefore applying shampoo.

After treatment

Wash your hands after applying product.

-Nit combing is not necessary whentreating with product for it to work, but ifdesired, a fne-tooth comb or special nitcomb may be used to remove dead liceand nits.This is a single use product, Discard

bottle after use.Do not use again on the same personand same lice infestation without talkingto a healthcare provider frst.If infestation continues, see a doctor forother treatments.

Machine wash any bedding and clothingused by anyone having lice, Machinewash at high temperatures (150°F) andtumble in a hot dryer for 20 minutes.After fnishing treatment with licemedicine, check everyone in your famillyfor lice after one week. Considertreatment for those who have lice.

Dosage and Administration

lotion, topical

Description

Ivermectin 0.5%

Section 50565-1

Keep out of reach of children.

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

Section 50569-3

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.

Section 50570-1

Breathing difficulty occurs.

Eye irritation occurs.

Skin or scalp irritation continues or infection occurs.

Rash develops.

Section 51727-6

Butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS,cyclomethicone, glycerin, imidurea, lanolinalcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium ditrate anhydrous,sorbitan tristearate and stearyl alcohol.

Section 51945-4

Kills Lice:

Just once is all it takes

IVERMET

0.5% Lice Treatment Lotion

ONCE

10 MINUTES!

NO MESS

NET WT: 4 OZ (125 mL)

Section 53413-1

925-899-0135

Section 53414-9

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

Section 55105-1

Lice Treatment

Section 55106-9

Ivermectin 0.5%


Structured Label Content

Indications and Usage (34067-9)

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 houschold members should be checked by anothe!person for lice and/or nits (eggs)

Use a magnifying glassin bright light to help you see

thelice and/or nits(eggs)

Use a tool, such as a comb or two unsharpened pencilsto lift and part the hair

Look for tiny nits near the scalp, beginning at the backof theneck and behind the ears

Examine small sections ofthe hair (1-2 inches wide) ata time

.Unlike dandruff, nits stick to the hair, Dandruff shouldmove when lightly touched

If either lice or nits (eggs) are found, treat with product

Treat

Your hair and scalp must be DRY before applyingproduct

Apply the product directly onto dry hair and scalp

Completely cover your scalp and hair closest to thescalp first.and then apply outwards towards the endsofyour hair

Use only as much asneeded to fully cover hair andscalp up to one full bottle, and discard the remainingRub product throughout your hair

Itis important to completely cover your entire head sothat all lice and eggs are exposed to the lotion, Be surethat each hair is coated from the scalp to the tip

Wait and Rinse

Allow product to stay on your hair and scalp for 10minutes after it has been applied, Use a timer or clockStart timing after you have completely covered yourhair and scalp with product.

After 10 minutes, rinse product completely from youhair and scalp using only water.

After rinsing, dry and style hair as usual. Wait 24 hoursbefore applying shampoo.

After treatment

Wash your hands after applying product.

-Nit combing is not necessary whentreating with product for it to work, but ifdesired, a fne-tooth comb or special nitcomb may be used to remove dead liceand nits.This is a single use product, Discard

bottle after use.Do not use again on the same personand same lice infestation without talkingto a healthcare provider frst.If infestation continues, see a doctor forother treatments.

Machine wash any bedding and clothingused by anyone having lice, Machinewash at high temperatures (150°F) andtumble in a hot dryer for 20 minutes.After fnishing treatment with licemedicine, check everyone in your famillyfor lice after one week. Considertreatment for those who have lice.

Dosage and Administration (34068-7)

lotion, topical

Warnings and Precautions (34071-1)

TAMPER EVIDENT: DO NOT USE IF THEPUMP IS DAMAGED OR SEAL IS BROKEN. Store at room temperature 68℃F-77°

Do not freeze.

keep carton and see Consumer Information Leaflet and warnings before use

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

Breathing difficulty occurs.

Eye irritation occurs.

Skin or scalp irritation continues or infection occurs.

Rash develops.

Section 51727-6 (51727-6)

Butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS,cyclomethicone, glycerin, imidurea, lanolinalcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium ditrate anhydrous,sorbitan tristearate and stearyl alcohol.

Section 51945-4 (51945-4)

Kills Lice:

Just once is all it takes

IVERMET

0.5% Lice Treatment Lotion

ONCE

10 MINUTES!

NO MESS

NET WT: 4 OZ (125 mL)

Section 53413-1 (53413-1)

925-899-0135

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Lice Treatment

Section 55106-9 (55106-9)

Ivermectin 0.5%


Advanced Ingredient Data


Raw Label Data

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