Spinosa O.9% Topical Soultion 60ml

Scabies Infestation
Age: 4 years and older, including children and adults
Use: Spinosa 0.9% topical solution is used for the topical treatment of scabies caused by mite infestation.

Head Lice Infestation
Age: 6 months and older, including children and adults
Use: It is indicated for the topical treatment of head lice infestation.

For external use only. Do not swallow or apply to the eyes or inside the vagina.

For Scabies

• Shake the bottle thoroughly before use.
• Apply the suspension evenly over the entire body from the neck down to the soles of the feet.
• People with a bald or partially bald scalp should also apply it to the scalp, hairline, temples, and forehead.
• Allow the medicine to remain on the skin and dry for approximately 10 minutes before getting dressed.
• Avoid bathing or washing the treated areas for at least 6 hours after application.

For Head Lice

• Shake the bottle well before application.
• Apply the solution thoroughly to dry hair and the entire scalp, ensuring complete coverage.
• Leave it on for 10 minutes.
• Rinse the hair thoroughly with warm water.
• If live lice are still present 7 days after the first treatment, a second treatment may be required as directed by the doctor.

Use in Children

• Scabies: Safety and effectiveness have not been established in children younger than 4 years.
• Head lice: It may be used in children aged 6 months and older.
• Products containing benzyl alcohol should not be used in infants younger than 6 months unless specifically directed by a healthcare professional.

Drug Interactions

Spinosad has very little systemic absorption, so significant drug interactions are unlikely. However, using it together with other topical products, such as corticosteroids or retinoids, may increase the chance of skin irritation or sensitivity.

Contraindications

There are no specific contraindications established, apart from avoiding use in patients with known sensitivity to the product or its ingredients.

Side Effects

Possible side effects include:

For scabies treatment:

• Skin irritation at the application site
• Dry skin

For head lice treatment:

• Redness of the skin at the application site
• Redness or irritation of the eyes

These reactions are generally localized to the treated area.

Pregnancy & Breastfeeding

Available data do not indicate significant systemic exposure following topical use. Pregnant women should consult their doctor before using Spinosa.

During breastfeeding, exposure of the infant is not expected to be significant. However, any medicine remaining on the breast should be thoroughly removed with soap and water before breastfeeding.

Precautions & Warnings

• Use Spinosa only on the skin or scalp as directed.
• Avoid contact with the eyes, mouth, and other mucous membranes.
• Do not use in infants younger than 6 months, as the formulation contains benzyl alcohol.
• Wash hands after application unless the hands themselves are being treated.
• Keep the medicine away from children and avoid accidental ingestion.

Therapeutic Class

Topical antiparasitic preparation

Storage

Store below 25°C in a dry place and protect from light. Keep the bottle tightly closed and out of the reach of children.