Vanalice Gel
FDA Label NDC 58809-650

14 label sections · Submitted to the FDA by Gm Pharmaceuticals, Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc for the product Vanalice (NDC 58809-650). 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, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Uses

treats head, pubic (crab), and body lice

Directions

  • Important: Read warnings before use Adults and children 2 years and over:
  • Inspect

    • check each household member with a magnifying glass in bright light for lice/nits (eggs)
    • look for tiny nits near scalp, beginning at back of neck and behind ears
    • examine small sections of hair at a time
    • unlike dandruff which moves when touched, nits stick to the hair
    • if either lice or nits are found, treat with this product
    • Treat

      • apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck.
      • allow product to remain for 10 minutes, but no longer
      • wash area thoroughly with warm water and soap or shampoo
      • for head lice, towel dry hair and comb out tangles
      • Remove lice and their eggs (nits)

        • use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
        • hair should remain slightly damp while removing nits
        • if hair dries during combing, dampen slightly with water
        • for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours.
        • lift a 1-to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.
        • pin back each strand of hair after combing
        • clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.
        • after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
        • check daily for any lice/nits that you missed
        • a second treatment must be done in 7 to 10 days to kill any newly hatched lice
        • if infestation continues, see a doctor for other treatments
        • Children under 2 years: ask a doctor

Other Information

  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat
  • keep carton for important product information
  • see Consumer Information Insert for additional information

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