FDA.reportPublic FDA data

GZE NIPPLE BALM

Manufacturer
Guangzhou Yilong Cosmetics Co., Ltd
Effective date
2024-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:00:30

Label at a glance#

ProductGZE NIPPLE BALM
Active ingredientSHEA BUTTER, COCONUT OIL, OLIVE OIL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

BUTYROSPERMUM PARKII (SHEA) BUTTER

COCOS NUCIFERA (COCONUT) OIL

OLEA EUROPAEA (OLIVE) FRUIT OIL

INACTIVE INGREDIENT SECTION

BEESWAX

TOCOPHEROL

BISABOLOL

AROMA

OTC - PURPOSE SECTION

Moisturising.

INDICATIONS & USAGE SECTION

Use anytime on sore, cracked nursing nipples to soften and smooth the skin.
It can also be used to moisturize lips, heels, elbows and other areas.

WARNINGS SECTION

For external use only.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

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

Take a coin-sized amount of cream, apply to desired area and massage until absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83566-048GZE NIPPLE BALM (BUTYROSPERMUM PARKII (SHEA BUTTER)) PASTE [GUANGZHOU YILONG COSMETICS CO., LTD]1Unmatched20240619_1b26fd17-9ba6-6e66-e063-6294a90a5d6e.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83566-04883566-048-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YACTIB
.BETA.-BISABOLOLLP618AV2EAIACT
COCONUT OILQ9L0O73W7LACTIB
TOCOPHEROLR0ZB2556P8IACT
PEG-8 BEESWAX3C1QUF1TIRIACT
AROMADENDRIN7YA4640575IACT
OLIVE OIL6UYK2W1W1EACTIB

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
39f4ae27-8c23-adaf-e063-6294a90a3ad31b26fd17-9ba6-6e66-e063-6294a90a5d6e2025-07-15WarningsExact identifier
spl set id: 1b26fd17-9ba6-6e66-e063-6294a90a5d6e

Reported adverse events (FAERS/openFDA)#

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