buybuyBABY

Manufacturer
Harmon Stores Inc.
Effective date
2021-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:29:19

Label at a glance#

ProductbuybuyBABY quick relief diaper rash cream
Active ingredientZINC OXIDE
Label structure10 sections

Storage and handling

Other information -store at 20 to 25 C    (68 to 77 F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide, 13.0%

OTC - PURPOSE SECTION

Purpose

Skin protectant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

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

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

-allow to dry  -apply cream liberally as often as necessary, with each diaper

change, especially at bedtime or at any time when exposure to wet diapers may

be prolonged

STORAGE AND HANDLING SECTION

Other information

-store at 20 to 25 C    (68 to 77 F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe barbadensis leaf juice, beeswax, dimethicone,

magnesium sulfate, methylparaben, microcrystalline wax,

mineral oil, PEG-30 dipolyhydroxystearate, petrolatum,

phenoxyethanol, polyglyceryl-3 diostearate,

potassium hydroxide, proprylparaben, sorbitan,

sesquioleate, tocopheryl acetate (vitamin E), water

DESCRIPTION SECTION

Maximum Strength Diaper Rash Paste provides maximum strength relief

overnight for baby's delicate skin. This rich and dermatologist-tested

formula instantly forms a protection layer

on your baby's skin to soothe and relieve discomfort caused

by diaper rash.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63940-113-172023-06-14C16284748780-1f386c649-b6e5-0266-e053-dadaa90a7c1abuybuyBABY

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-11363940-113-16, 63940-113-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
feb5cd45-65e8-202a-e053-6394a90aa81fac222d2c-aee5-4ff3-926c-dbc7b50f108f2023-06-22WarningsExact identifier
spl set id: ac222d2c-aee5-4ff3-926c-dbc7b50f108f

Reported adverse events (FAERS/openFDA)#

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