Smarth
FDA Label NDC 71486-8020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Glint Cosmetics Private Limited for the product Smarth (NDC 71486-8020). 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 3.8%

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 an ■ 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 doesn't 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 and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Inactive Ingredients

Aloe Barbadensis Gel, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea Mays Oil, Fragrance Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Borate, Tocopheryl Acetate (Vitamin E) Water, White Petrolatum

* Please review the disclaimer below.