AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:02:19

Label at a glance#

ProductAD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide
Active ingredientDIMETHICONE, ZINC OXIDE
Label structure10 sections

Indications and uses

helps treat and prevent diaper rash protects minor skin irritation due to diaper rash and helps seal out wetness

Dosage and administration

change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply cream 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

store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Zinc Oxide 10%

Purpose 

OTC - PURPOSE SECTION

Diaper Rash Cream 

Diaper Rash Cream 

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • aloe barbadensis leaf extract, benzyl alcohol, cocos nucifera (coconut) oil, cod liver oil (contains vitamin A & vitamin D), fragrance, glyceryl monooleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water

Questions?

OTC - QUESTIONS SECTION

1-844-241-5454

Distributed by:

SPL UNCLASSIFIED SECTION

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243

© 2023 WellSpring Pharmaceutical Corporation

www.ADskinhealth.com

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Treat & Heal Cream Diaper Rash Zinc Cream

FAST-ACTING, MOISTURIZING ZINC FORMULA

With Vitamins A+D

plu

Aloe Vera

Allows skin to heal naturally

Calms diaper rash on contact

NET WT 4 OZ (113g)

CT40200C
CT40200C

A+D Treat Zinc Ointment 454g.

SPL UNCLASSIFIED SECTION

NET WT1 LB (454g)

LF40216A
LF40216A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
686403dimethicone 1 % / zinc oxide 10 % Topical CreamPSN7
686403dimethicone 10 MG/ML / zinc oxide 100 MG/ML Topical CreamSCD7
686403dimethicone 1 % / zinc oxide 10 % Topical CreamSY7
686403dimethicone 10 MG/ML / ZNO 100 MG/ML Topical CreamSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-402-00AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide1 in 1 BOXCREAM17
65197-402-00AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide113 g in 1 TUBECREAM1137
65197-402-16AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide454 g in 1 JARCREAM4547

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-402-00GM - Gram65197-4020900c8fa-09df-4a40-94dd-79e707ef4cf912024-03-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65197-40265197-402-00, 65197-402-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
82632391-efd7-45f8-bd24-77ce6c407f9ddc794a75-cd69-4658-b164-4182a86d90df2025-06-04WarningsExact identifier
spl id: 82632391-efd7-45f8-bd24-77ce6c407f9d
spl set id: dc794a75-cd69-4658-b164-4182a86d90df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.