FDA.reportPublic FDA data

Baby Balm Stick 0.65oz

Manufacturer
Rejoice International Corp. | China Ningbo Shangge Cosmetics Technology Corp.
Effective date
2024-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:11

Label at a glance#

ProductBaby Balm Stick 0.65oz
Active ingredientPETROLATUM
Label structure8 sections

Dosage and administration

Apply as needed.

Storage and handling

For best product quality, store below 113°F/45°C.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatun 30%

Purpose

OTC - PURPOSE SECTION

Skin Protectant (Ointment)

Use

INDICATIONS & USAGE SECTION

  • temporarily protects minor;
  • cut
  • scrapes
  • burns
  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7days or clear up and occur again within a few days.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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

Apply as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil

polyisobutene

polyisobutene

beeswax

microcrystalline wax

butyrospermum parkii (shea butter) oil

BHT

Bisabolol

Glycerin

Tocopherol

Panthenol

Other information

STORAGE AND HANDLING SECTION

For best product quality, store below 113°F/45°C.

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417854petrolatum 30 % Topical OintmentPSN1
417854petrolatum 0.3 MG/MG Topical OintmentSCD1
417854petrolatum 30 % Topical OintmentSY1
417854petrolatum 30 % Topical StickSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-167-01Baby Balm Stick 0.65oz18.4 g in 1 TUBEOINTMENT18.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-167BABY BALM STICK 0.65OZ (PETROLATUM) OINTMENT [REJOICE INTERNATIONAL CORP.]1Current NDC, 1 package rows20240830_20cf3bb8-4ab8-2980-e063-6294a90ad631.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-16757337-167-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
SHEANUT OILO88E196QRFIACT
TOCOPHEROLR0ZB2556P8IACT
PANTHENOLWV9CM0O67ZIACT
PETROLATUM4T6H12BN9UACTIB
GLYCERINPDC6A3C0OXIACT
CERESINQ1LS2UJO3AIACT
LEVOMENOL24WE03BX2TIACT
MINERAL OILT5L8T28FGPIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
POLYISOBUTYLENE (1300 MW)241BN7J12YIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT

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
Baby Balm Stick 0.65ozPETROLATUMRejoice International Corp.20cf3bb8-4ab8-2980-e063-6294a90ad6312024-08-29WarningsExact identifier
ndc (package): 57337-167-01
ndc (product): 57337-167
ndc11 (package): 57337016701
spl id: 20cf2891-c087-29b4-e063-6294a90a41e8
spl set id: 20cf3bb8-4ab8-2980-e063-6294a90ad631

Reported adverse events (FAERS/openFDA)#

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