Astonea Skin Protectant Ointment
FDA Label NDC 77338-050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astonea Labs Private Limited for the product Astonea Skin Protectant (NDC 77338-050). 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:, when using this product, stop use and ask a doctor if:, keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide (1.8% w/w)

Purpose

Skin Protectant

Uses:

  • Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
  • Protects Skin against irritation due to such rash and
  • Helps protect skin from exposure to wetness

Warnings:

For external use only

When Using This Product

  • Avoid contact with eyes
  • If eye contact occurs, flush with water

Stop Use And Ask A Doctor If:

  • Condition worsens or does not improve within seven days

Keep Out Of Reach Of Children

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

Directions:

  • Change wet or solied diapers promptly
  • Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs
  • Allow to dry
  • Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged

Other Information:

  • Store at room temperature 15° - 30°C (59° - 86°F)
  • Avoid excessive heat

Inactive Ingredients:

Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, Vitamin A Palmitate, Water.

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