Ozipco Ivermectin Lotion
FDA Label NDC 86241-113

16 label sections · Submitted to the FDA by Fast Sold Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fast Sold Llc for the product Ozipco Ivermectin (NDC 86241-113). 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 drug listing data elements, 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

Drug Listing Data Elements

OZIPCO Ivermectin Lotion 0.5% Lice Treatment

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

Pregnancy Or Breast-Feeding

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

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 for lice and/or nits (eggs).

Hair and scalp must be dry before applying product. Apply product directly to dry hair and scalp. Completely cover scalp and hair closest to the scalp first, then apply outward toward the ends. Use only the amount needed to completely cover hair and scalp, up to 1 entire tube. Rub product throughout hair.

Allow product to stay on hair and scalp for 10 minutes after it has been applied. After 10 minutes, rinse completely using only water.

After rinsing, dry and style as usual. Wait 24 hours before applying shampoo.

Wash hands after applying product. Nit combing is not necessary. This is a single-use product. Discard tube after use. If infestation continues, see a doctor for other treatments.

Other Information

TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN.

Store at room temperature 68°F to 77°F (20°C to 25°C). Do not freeze.

Keep carton and see Consumer Information Leaflet and warnings before use.

Inactive Ingredients

butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, Crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate, stearyl alcohol

Other Labeling Information

Questions or comments? 1-502-922-6432

DISTRIBUTED BY: Fast Sold LLC, Avocado Ave Unit 5, Melbourne, Florida 32935, USA.

www.fastsoldllc.com

Package Label.Principal Display Panel

OZIPCO Ivermectin Lotion 0.5% Lice Treatment

NDC 86241-113-01

NET WT. 4 oz (117 g)

Ozipco Ivermectin Lotion 0.5% 117 G Carton Label (Ozipco Ivermectin Lotion 05 117g Label)

Ozipco Ivermectin Lotion 0.5% 117 G Carton Label (Ozipco Ivermectin Lotion 05 117g Label)

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