FDA.reportPublic FDA data

baby wipes

Manufacturer
Jinhua Huihuang Non-woven Products Co., Ltd.
Effective date
2020-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:30:11

Label at a glance#

Productbaby wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Wipe hands, discard properly in trash receptacle. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store at room temperature. Do not store above 105℉. Do not freeze May discolor some fabrics. Harmful to wood finishes and plastics. Effective at eliminating more than 99.99% of many common harmful germs and bacteriain as little as 15 seconds.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand sanitizing that helps reduce bacteria on the skin, recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only.
  • Highly Flammable - Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • On open skin wounds.

OTC - WHEN USING SECTION

  • Avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush with water.
  • Avoid contact with broken skin. Do not inhale or ingest.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a Poison Control Center or a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe hands, discard properly in trash receptacle.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature. Do not store above 105℉.
  • Do not freeze
  • May discolor some fabrics. Harmful to wood finishes and plastics.
  • Effective at eliminating more than 99.99% of many common harmful germs and bacteriain as little as 15 seconds.

Inactive ingredients

INACTIVE INGREDIENT SECTION

2-Bromo-2-nitro-1,3-propanediol, Chitosan, Polysorbate 20, Propylene Glycol, Citric Acid, Purified Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:54016-005-01 60PCS 54016-005-0154016-005-01

NDC:54016-005-02 1PCS 54016-005-0254016-005-02

NDC:54016-005-03 10PCS

54016-005-0354016-005-03

NDC:54016-005-04 15PCS

54016-005-0454016-005-04NDC:54016-005-05 20PCS

2020NDC:54016-005-06 25PCS

2525NDC:54016-005-07 30PCS

3030NDC:54016-005-08 40PCS

4040NDC:54016-005-09 50PCS

5050NDC:54016-005-10 80PCS

8080NDC:54016-005-11 90PCS

9090NDC:54016-005-12 100PCS

100100NDC:54016-005-13 120PCS

120120NDC:54016-005-14 150PCS

150150

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54016-005-012022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-022022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-032022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-042022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-052022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-062022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-072022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-082022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-092022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-102022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-112022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-122022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-132022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01
54016-005-142022-01-28C16284748780-1d6a99b39-7c67-a426-e053-dadaa90af4c2baby wipes 60pcs NDC: 54016-005-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54016-005-01baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-01baby wipes60 in 1 PACKETCLOTH602
54016-005-02baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-02baby wipes1 in 1 PACKETCLOTH12
54016-005-03baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-03baby wipes10 in 1 PACKETCLOTH102
54016-005-04baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-04baby wipes15 in 1 PACKETCLOTH152
54016-005-05baby wipes20 in 1 PACKETCLOTH202
54016-005-05baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-06baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-06baby wipes25 in 1 PACKETCLOTH252
54016-005-07baby wipes30 in 1 PACKETCLOTH302
54016-005-07baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-08baby wipes40 in 1 PACKETCLOTH402
54016-005-08baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-09baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-09baby wipes50 in 1 PACKETCLOTH502
54016-005-10baby wipes80 in 1 PACKETCLOTH802
54016-005-10baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-11baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-11baby wipes90 in 1 PACKETCLOTH902
54016-005-12baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-12baby wipes100 in 1 PACKETCLOTH1002
54016-005-13baby wipes120 in 1 PACKETCLOTH1202
54016-005-13baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-14baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-14baby wipes150 in 1 PACKETCLOTH1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54016-005BABY WIPES CLOTH [JINHUA HUIHUANG NON-WOVEN PRODUCTS CO., LTD.]2Legacy NDC, 28 package rows20200925_aef07b16-36f6-19de-e053-2a95a90a5c70.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
54016-00554016-005-01, 54016-005-02, 54016-005-03, 54016-005-04, 54016-005-05, 54016-005-06, 54016-005-07, 54016-005-08, 54016-005-09, 54016-005-10, 54016-005-11, 54016-005-12, 54016-005-13, 54016-005-14

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BRONOPOL6PU1E16C9WIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYSORBATE 207T1F30V5YHIACT
POLIGLUSAM82LKS4QV2YIACT

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
b01b2e02-d065-7413-e053-2995a90a0913aef07b16-36f6-19de-e053-2a95a90a5c702020-09-24WarningsExact identifier
spl id: b01b2e02-d065-7413-e053-2995a90a0913
spl set id: aef07b16-36f6-19de-e053-2a95a90a5c70

Reported adverse events (FAERS/openFDA)#

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