SPL v1
SPL
SPL Set ID 459b4316-89df-0bb1-e063-6294a90a518d
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
Glycerin Anhydrous Citric Acid Shea Butter Sorbitan Tristearate Methylparaben Propylene Glycol Propylparaben Water Anhydrous Trisodium Citrate Stearyl Alcohol Butylated Hydroxyanisole Oleyl Alcohol Cetyl Alcohol Imidurea Cyclomethicone Lanolin Alcohols Olive Oil Castor Oil

Identifiers & Packaging

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

Description

Ivermectin


Medication Information

Warnings and Precautions

TAMPER EVIDENT: DO NOT USE IF THE PUMP 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

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, cetylalcohol, citric acid anhydrous, crodalan AWS,cyclomethicone, glycerin, imidurea, lanolinalcohols, methylparaben, oleyl alcohol, oliveoil, propylene glycol, propylparaben, purifedwater, shea butter, sodium citrate anhydroussorbitan tristearate and stearyl alcohol

Section 51945-4

IVORMETN

Ivermectin

Lotion, 0.5%

Lice Treatment

No second application required

Not nit combing required

Ivermectin lotion kills lice

One Bottle

One Time

10 Minutes

NET WT 4.4 OZ (125 g)

Section 53414-9

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

Section 55105-1

Lice treatment

Section 55106-9

Ivermectin


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 THE PUMP 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, cetylalcohol, citric acid anhydrous, crodalan AWS,cyclomethicone, glycerin, imidurea, lanolinalcohols, methylparaben, oleyl alcohol, oliveoil, propylene glycol, propylparaben, purifedwater, shea butter, sodium citrate anhydroussorbitan tristearate and stearyl alcohol

Section 51945-4 (51945-4)

IVORMETN

Ivermectin

Lotion, 0.5%

Lice Treatment

No second application required

Not nit combing required

Ivermectin lotion kills lice

One Bottle

One Time

10 Minutes

NET WT 4.4 OZ (125 g)

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


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Raw Label Data

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