Quality Choice Maximum Strength Zinc Oxide
FDA Label NDC 63868-500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Quality Choice Maximum Strength Zinc Oxide (NDC 63868-500). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                       Purpose

Zinc oxide 40%...................................................... Skin Protectant

Otc - Purpose

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness

Warnings

Warnings

For external use only

Otc - When Using

When using this product

  • avoid contact with the eyes

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 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.

Indications & Usage

Directions

  • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged

Storage And Handling

Other information

  • store at 20°-25°C (68°-77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients butylhydroxyanisole, lavender oil, methylparaben, purified lanolin, purified water, squalane, talc, white petrolatum

Dosage & Administration

DISTRIBUTED BY:

C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995

www.qualitychoice.com

MADE IN KOREA

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