Zinc Oxide
FDA Label NDC 83514-0020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ab Brands, Llc for the product Zinc Oxide (NDC 83514-0020). 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 ingredients, 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 Ingredients

Zinc oxide 40%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When Using This Product

do not get into eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

  • change wet and soilded diapers promptly
  • cleanse the diaper area
  • 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

Other Information

store between 20⁰ and 25⁰C (68⁰ and 77⁰F)

Inactive Ingredients

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

Questions?

Call 1-877-662-3288

Claims - Side Panel

RELIEF YOU CAN FEEL

40% ZINC OXIDE

5-IN-1 COMFORT HELPS

  • TREAT
  • PREVENT
  • PROTECT
  • SOOTHE
  • RELIEVE

Back Panel - Claims & Adverse Reactions

Aquation 

Diaper Rash Ointment

Made with 40% Zinc Oxide to help treat and protect chafed skin and skin irritations caused by rash. Aquation spreads easily to seal out wetness forming a protective layer to relieve discomfort. 

40% ZINC OXIDE

Skin protectant made with

GLYCERIN 

VITAMIN E

HYPOALLERGENIC

PEDIATRICIAN TESTED

DERMATOLOGIST TESTED

No parabens, phthalates, talc, dyes or DEA

*Maximum strength zinc oxide diaper rash ointment available under product monograph.

WOMEN OWNED 

WOMEN OWNED

www.aquationcare.com

Aquation is a registed trademark of AB Brands, LLC.

Made in the USA with domestic & foreign materials.

American-owned. Not tested on animals.

Distributed by AB Brands, LLC Dallas, TX 75219

Principal Display Panel

NEW!

Aquation 

DIAPER RASH OINTMENT

Skin Protectant

40% ZINC OXIDE

GLYCERIN

VITAMIN E

Helps treat diaper rash

Soothes irritated skin and blocks moisture

No parabens, phthalates, talc or dyes

MAX STRENGTH

NET WT 4 OZ/113 g

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.