Zinc oxide by AB Brands, LLC / Nice-Pak Products, LLC ZINC OXIDE ointment

Zinc oxide by

Drug Labeling and Warnings

Zinc oxide by is a Otc medication manufactured, distributed, or labeled by AB Brands, LLC, Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 soiled 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 

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

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83514-0020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83514-0020-4	1 in 1 CARTON	06/06/2023
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/06/2023

Labeler - AB Brands, LLC (080512621)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(83514-0020)