Dermaka Infants And Kids Multi Purpose Skin Protectant Ointment
FDA Label NDC 82240-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermaka Skin Products Llc for the product Dermaka Infants And Kids Multi Purpose Skin Protectant (NDC 82240-014). 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 facts, active ingredient(s), purpose(s), use(s):, warning(s):, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient(S)

Zinc Oxide 25.0%

Purpose(S)

Skin Protectant

Use(S):

  • Temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • Temporarily protects chapped or cracked skin.
  • Dries the oozing and weeping of poison:
  • ivy
  • oak
  • sumac

Warning(S):

For external use only.

Do Not Use

  • on deep or puncture wounds, animal bites or serious burns.

When Using This Product

  • do not get into eyes.

Stop Use And Ask A Doctor If

condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

  • Apply as needed.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Beeswax, Bisabolol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter

Questions?

(772) 266-3376

Package Labeling: 5Ml

Label (Label)

Label (Label)

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