FDA.reportPublic FDA data

Baby Wipes

Manufacturer
Shandong Yayun Sanitary Products Co., Ltd.
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:38:43

Label at a glance#

ProductBaby Wipes
Active ingredientPROPYLENE GLYCOL
Label structure12 sections

Dosage and administration

Wipe the surface of the skin and let it dry naturally Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Baby Wipes

Purpose

OTC - PURPOSE SECTION

Antiseptic, Baby Wipes

Use

INDICATIONS & USAGE SECTION

Baby Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Wipe the surface of the skin and let it dry naturally
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER
Aloe Barbadensis Leaf Extract
Chamomile Extract
Phenoxyethanol
DMDM Hydantoin
Ethylhexylglycerin
Benzalkonium Chloride

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79539-401-01Baby Wipes1 in 1 BAGCLOTH15
79539-401-02Baby Wipes10 in 1 BAGCLOTH105
79539-401-03Baby Wipes20 in 1 BAGCLOTH205
79539-401-04Baby Wipes30 in 1 BAGCLOTH305
79539-401-05Baby Wipes40 in 1 BAGCLOTH405
79539-401-06Baby Wipes50 in 1 BAGCLOTH505
79539-401-07Baby Wipes60 in 1 BAGCLOTH605
79539-401-08Baby Wipes70 in 1 BAGCLOTH705
79539-401-09Baby Wipes80 in 1 BAGCLOTH805
79539-401-10Baby Wipes100 in 1 BAGCLOTH1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79539-401BABY WIPES (PROPYLENE GLYCOL) CLOTH [SHANDONG YAYUN SANITARY PRODUCTS CO., LTD.]5Current NDC, Legacy NDC, 10 package rows20241123_aeb9a12c-955f-5030-e053-2995a90a2dd6.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
79539-40179539-401-01, 79539-401-02, 79539-401-03, 79539-401-04, 79539-401-05, 79539-401-06, 79539-401-07, 79539-401-08, 79539-401-09, 79539-401-10

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
PROPYLENE GLYCOL6DC9Q167V3ACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
DISODIUM HEDTAKME849MC7AIACT
AQUA059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CANANGA OIL8YOY78GNNXIACT
SODIUM CITRATE1Q73Q2JULRIACT
TEA TREE OILVIF565UC2GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
GLYCERINPDC6A3C0OXIACT

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 WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
ndc (package): 79539-401-05
ndc (package): 79539-401-02
ndc (package): 79539-401-06
ndc (package): 79539-401-01
ndc (package): 79539-401-03
ndc (package): 79539-401-04
ndc (package): 79539-401-09
ndc (package): 79539-401-07
ndc (package): 79539-401-10
ndc (package): 79539-401-08
ndc (product): 79539-401
ndc11 (package): 79539040106
ndc11 (package): 79539040104
ndc11 (package): 79539040110
ndc11 (package): 79539040109
ndc11 (package): 79539040101
ndc11 (package): 79539040108
ndc11 (package): 79539040102
ndc11 (package): 79539040105
ndc11 (package): 79539040103
ndc11 (package): 79539040107
spl id: 27641d80-1c29-5893-e063-6394a90aa0c3
spl set id: aeb9a12c-955f-5030-e053-2995a90a2dd6

Reported adverse events (FAERS/openFDA)#

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