FDA.reportPublic FDA data

Triple Paste ® Diaper Rash Ointment

Manufacturer
Advantice Health, LLC
Effective date
2026-03-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:50:53

Label at a glance#

ProductTriple Diaper Rash
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness

Dosage and administration

change wet and soiled diapers promptly cleanse the diaper area and allow skin to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any lime exposure to wet diapers may be prolonged

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 12.8%

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 protect from wetness

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this productdo 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.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 skin to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any lime exposure to wet diapers may be prolonged

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

white petrolatum, com starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerin, oat (avena saliva) kernel extract.

Questions?

OTC - QUESTIONS SECTION

1-800-345-0032

SPL UNCLASSIFIED SECTION

Distributed by Advantice Health, LLC
Cedar Knolls, NJ 07927

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEDIATRICIAN RECOMMENDED

TRIPLE PASTE ®
12.8% Zinc Oxide / Skin Protectant

All-in-One

TRIPLE PROTECTION

PREVENTS
stops diaper rash before it starts

TREATS
restores irritated skin to health

SOOTHES
immediate soothing relief for sensitive skin

•Fragrance-free•

Net Wt. 3oz. (85g)

Principal Display Panel - 85 g Tube Carton
Principal Display Panel - 85 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
729935TRIPLE PASTE 12.8 % Topical OintmentPSN6
637168zinc oxide 12.8 % Topical OintmentPSN6
729935zinc oxide 0.128 MG/MG Topical Ointment [Triple Paste]SBD6
637168zinc oxide 0.128 MG/MG Topical OintmentSCD6
729935Triple Paste 0.128 MG/MG Topical OintmentSY6
729935Triple Paste 12.8 % Topical OintmentSY6
637168zinc oxide 12.8 % Topical OintmentSY6
637168ZNO 0.128 MG/MG Topical OintmentSY6
729935ZNO 0.128 MG/MG Topical Ointment [Triple Paste]SY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-021-01Triple Diaper Rash1 in 1 CARTONOINTMENT16
16864-021-01Triple Diaper Rash57 g in 1 TUBEOINTMENT576
16864-021-02Triple Diaper Rash1 in 1 CARTONOINTMENT16
16864-021-02Triple Diaper Rash85 g in 1 TUBEOINTMENT856
16864-021-03Triple Diaper Rash227 g in 1 JAROINTMENT2276
16864-021-04Triple Diaper Rash283 g in 1 JAROINTMENT2836
16864-021-05Triple Diaper Rash454 g in 1 JAROINTMENT4546
16864-021-06Triple Diaper Rash1 in 1 CARTONOINTMENT16
16864-021-06Triple Diaper Rash11.5 g in 1 TUBEOINTMENT11.56
16864-021-07Triple Diaper Rash6 g in 1 PACKETOINTMENT66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-021-01GM - Gram16864-021e8c9a740-660a-4885-a286-109a7717932c12023-01-09
16864-021-05GM - Gram16864-0210eed86da-4c82-4c0d-920f-7271d41a854212023-01-09

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16864-02116864-021-03, 16864-021-04, 16864-021-05, 16864-021-02, 16864-021-01, 16864-021-06, 16864-021-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE PETROLATUMB6E5W8RQJ4IACT
STARCH, CORNO8232NY3SJIACT
LANOLIN7EV65EAW6HIACT
STEARYL ALCOHOL2KR89I4H1YIACT
YELLOW WAX2ZA36H0S2VIACT
LEVOMENOL24WE03BX2TIACT
CHOLESTEROL97C5T2UQ7JIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OATZ6J799EAJKIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Triple Diaper RashZINC OXIDEAdvantice Health, LLCd457c58d-8239-41c4-999e-d0ba237e39452026-03-19WarningsExact identifier
ndc (package): 16864-021-05
ndc (package): 16864-021-02
ndc (package): 16864-021-07
ndc (package): 16864-021-03
ndc (package): 16864-021-06
ndc (package): 16864-021-01
ndc (package): 16864-021-04
ndc (product): 16864-021
ndc11 (package): 16864002104
ndc11 (package): 16864002105
ndc11 (package): 16864002103
ndc11 (package): 16864002106
ndc11 (package): 16864002107
ndc11 (package): 16864002102
ndc11 (package): 16864002101
spl id: 4d63f2a2-f114-d739-e063-6394a90a2d27
spl set id: d457c58d-8239-41c4-999e-d0ba237e3945

Reported adverse events (FAERS/openFDA)#

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