Premier Value Zinc Oxide
FDA Label NDC 68016-252

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 Consortium, Llc for the product Premier Value Zinc Oxide (NDC 68016-252). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, 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 20%.............................................................Skin protectant

Otc - Purpose

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips

Warnings

Warnings For external use only

Otc - Do Not Use

Do not use over deep or puncture wounds, infections or lacerations

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 ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients aloe vera gel, liquid paraffin, tocopherol acetate, white beeswax, white petrolatum

Dosage & Administration

Distributed By

Chain Drug Consortium

3301 NW Boca Raton Blvd. Suite 101

Boca Raton, FL 33431

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Pvzinc)

Image Of Carton Label (Pvzinc)

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