FDA.reportPublic FDA data

CVS Health Maxium Strength Diaper Rash ointment

Manufacturer
CVS Health | Sheffield Pharmaceuticals, LLC
Effective date
2018-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:53:04

Label at a glance#

ProductCVS Health Diaper Rash
Active ingredientZINC OXIDE
Label structure10 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

change wet and soiled diapers promptly cleanse the diaper area, and 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 40%

Purpose

OTC - PURPOSE SECTION

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

SPL UNCLASSIFIED SECTION

When using this product

OTC - WHEN USING SECTION

  • avoid contact with 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 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

OTHER SAFETY INFORMATION

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Glycerin, Cod Liver Oil, Sorbitan Sesquioleate, Lanolin, Beeswax, Talc, Tocopheryl Acetate, Fragrance

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diaper Rash 

Ointment

40% Zinc Oxide Skin Protectant

• Promotes healing

• Relieves chafing

• Paraben & phthalate free

Helps Treat and
Prevent Diaper Rash

24 Packettes

NET WT. 0.10 oz(3G) Each

Total -2.4 oz (68G)

Principal Display Panel - Carton LabelPrincipal Display Panel - Carton Label

Principal Display Panel - Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Diaper Rash
Ointment

40% Zinc Oxide Skin Protectant

  • Promotes Healing 
  • Relieves chafing 
  • Paraben and phthalate free

NET WT 0.10 oz(3G)

Principal Display Panel - Packet Label
Principal Display Panel - Packet Label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-70269842-702-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT
TALC7SEV7J4R1UIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
YELLOW WAX2ZA36H0S2VIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
6a04d706-519a-431e-9fef-f86dcd1d62377e53f282-dd04-4c6d-8ccc-55d2d763b8c32024-11-12WarningsExact identifier
spl set id: 7e53f282-dd04-4c6d-8ccc-55d2d763b8c3

Reported adverse events (FAERS/openFDA)#

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