X-pel Pure Anti-lice
FDA Label NDC 11727-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermedics Laboratories for the product X-pel Pure Anti-lice (NDC 11727-007). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Apis Mellifica 15x

Carbolicum Acidum 15x

Ledum Palustre 15x

Otc - Purpose

NON-TOXIC

Professional Formula

X-PEL PURE

Anti-Lice Shampoo & Conditioner

  • Eliminates Lice
  • Works in Just 10 Minutes
  • Stops Itching
  • Eases Egg Removal
  • Leaves Hair Soft, Shiny & Tangle-Free
  • Repels Lice
  • Pediatrician and Dermatologist Approved

    • 6 fl. oz. (177 mL)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Indications

For treatment of pediculosis.

  • Eliminates Lice
  • Makes eggs easy to remove
  • Stops itching caused by lice bites

Warnings

Warnings

For external use only. Avoid contact with eyes.

If eye contact occurs, rinse with clear water.

Keep out of reach of children.

Safe for ragweed sufferers.

Dosage & Administration

Directions

SHAKE WELL BEFORE USE

1. Wet hair with warm water.

2. Apply X-PEL™ liberally and massage into wet hair until a thick lather forms.

3. Leave lather on hair for 10 minutes. Do not rinse.

4. Divide hair into sections and comb with the NitPro-II™ comb to remove lice and eggs. Rinse comb after each stroke. For instructions on how to use the comb read the insert inside the box.

5. Rinse hair with warm water. Repeat steps 2-4.

6. Finally, rinse the hair with warm water, towel dry and inspect for and comb out any remaining eggs. Clean comb with hot water and store for future use.

Inactive Ingredient

Other ingredients

water, decyl glucoside, lauryl glucoside, pyroligeneous acid purified (USP), glycerine (USP), xanthan gum, potassium sorbate, sodium benzoate

Other Safety Information

Cruelty Free Testing

Environmentally Safe

Homeopathic Formula

Distributed By: Dermedics Laboratories

3900 Park Avenue, Suite 8-S, Bridgeport, CT 06604

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