FDA.reportPublic FDA data

CVS Diaper Rash

Manufacturer
CVS Health
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:36:49

Label at a glance#

ProductCVS Diaper Rash
Active ingredientZINC OXIDE, DIMETHICONE
Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash  Protects chafed skin due to diaper rash and helps seal out wetness 

Dosage and administration

use after each diaper change.  apply cream liberally to keep moisture away during night time or extended exposure to wetness.  use as needed. 

Label contents#

Full prescribing information#

Drug Facts 

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient 

Dimethicone,  1% 

Zinc Oxide,  10%

Purpose 

OTC - PURPOSE SECTION

Skin Protectant 

Skin Protectant 

Uses 

INDICATIONS & USAGE SECTION

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

Warnings 

WARNINGS SECTION

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.

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

  • use after each diaper change. 
  • apply cream liberally to keep moisture away during night time or extended exposure to wetness. 
  • use as needed. 

Inactive ingredients 

INACTIVE INGREDIENT SECTION

 Inactive Ingredients: Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Caprylic/Capric Triglyceride, Ceresin Wax (Ozokerite), Cocos Nucifera (Coconut) Oil, Cod Liver Oil (contains Vitamins A & D), Fragrance, Glyceryl Monooleate, Mineral Oil, Paraffin, Propylene Glycol, Sorbitol, Water (purified)

Other information 

OTHER SAFETY INFORMATION

Store between 20°-25°C (68°-77°F)

Questions ? 

OTC - QUESTIONS SECTION

1800-222-1087

Principal Display panel -Tube 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Diaper Rash Cream with A&D       NDC 51316-625-40

Dimethicone 1% Skin Protectant 

Zinc Oxide 10% Skin Protectant 

NET WT 4.0 oz ( 113g)

25031192_ZincOxideDiaperCream_wAD_Tube25031192_ZincOxideDiaperCream_wAD_Tube

Principal Display Panel -Carton 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Diaper Rash Cream with A&D NDC 51316-625-40

Dimethicone 1% Skin Protectant

Zinc Oxide 10% Skin Protectant

NET WT 4.0 oz ( 113g)

5031181_ZincOxideDiaperCream_wAD_Carton5031181_ZincOxideDiaperCream_wAD_Carton

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
51316-625-40CVS Diaper Rash1 in 1 CARTONOINTMENT13
51316-625-40CVS Diaper Rash113 g in 1 TUBEOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-625CVS DIAPER RASH (ZINC OXIDE AND DIMETHICONE) OINTMENT [CVS HEALTH]32 package rows20241114_60e71d7b-ee69-4168-9ff7-ad9ce4e19ccb.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-62551316-625-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
BENZYL ALCOHOLLKG8494WBHIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CERESINQ1LS2UJO3AIACT
COCONUT OILQ9L0O73W7LIACT
COD LIVER OILBBL281NWFGIACT
GLYCERYL MONOOLEATEC4YAD5F5G6IACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT

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
b01dbf09-9523-4ac2-8d83-c8505e4ee7e560e71d7b-ee69-4168-9ff7-ad9ce4e19ccb2024-11-12WarningsExact identifier
spl id: b01dbf09-9523-4ac2-8d83-c8505e4ee7e5
spl set id: 60e71d7b-ee69-4168-9ff7-ad9ce4e19ccb

Reported adverse events (FAERS/openFDA)#

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