Lanolin
FDA Label NDC 67777-232

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Lanolin (NDC 67777-232). 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 active ingredient, purpose:, warnings, keep out of reach of children, indications & usage, dosage & administration, other information:, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active ingredient               Purpose
Lanolin USP 50%                    Skin Protectant

Purpose:

  • Helps prevent and treat diaper dermatitis
  • Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness

Warnings

For External Use Only

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

  • If swallowed, get medical help or contact a Poison Control Center right away

Indications & Usage

  • Avoid contact with eyes
  • Do not apply to deep or puncture wounds
  • If condition worsens, or does not improve within 7 days, consult a doctor

Dosage & Administration

  • Gently cleanse and dry area
  • Apply liberally to affected area as needed

Other Information:

  • Store at room temperature 20 deg C to 25 deg C 68 deg F to 77 deg F

Inactive Ingredients

Beeswax (Yellow Wax), Fragrance, HEEDTA, Lanolin alcohol, Mineral oil, Oxyguinoline, Petrolatum, Purified water, Sodium borate, Sorbitan sesquioleate

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Lanolin (Lanolin)

Lanolin (Lanolin)

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