Endit Zinc Oxide Skin Protectant Ointment
FDA Label NDC 64068-402

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Endit Laboratories, Inc. for the product Endit Zinc Oxide Skin Protectant (NDC 64068-402). 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:, uses:, warnings:, otc - keep out of reach of children, directions:, other ingredients:, package labeling:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Zinc Oxide 20.00%

Purpose:

Skin Protectant

Uses:

Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urine. Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings:

For external use only.

When using this product do not get in eyes.

Stop use and ask doctor if

Condition worsens.

Symptoms last more than 7 days or clear up and occur again within a few days.

Otc - 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.

Directions:

  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry.
  • Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled dapers (feces, and/or urine) may be prolonged.

Other Ingredients:

Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum

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