Zinc Oxide
FDA Label NDC 11822-0081

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Riteaid for the product Zinc Oxide (NDC 11822-0081). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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                      PurposeZinc Oxide........................................Skin protectant

Otc - Purpose

Active ingredient                 PurposeZinc Oxide.................................Skin protectantUses- dries the oozing and weeping od poison - ivy - oak - sumac- helps treat and prevent diaper rash- protects chafed skin associated with diaper rash and helps protect from wetness

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Uses- dries the oozing and weeping od poison - ivy - oak - sumac- helps treat and prevent diaper rash- protects chafed skin associated with diaper rash and helps protect from wetness

Warnings

Warnings For external use only. When using this product do not get into eyesStop use and ask a doctor if:- condition worsens  - symptoms last more than 7 days or clearup and occur again within a few days.Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away

Dosage & Administration

Directions- apply as neededFor diaper rash- change wet and soiled diapers promptly - cleanse the diaper area, and allow to dry- apply liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged- children under 12 yearsask a doctorOther informationStore at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

Inactive Ingredient

Inactive Ingredientsbeeswax, mineral oil, petrolatum

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