FDA.reportPublic FDA data

Pouch Wipes

Manufacturer
Broder Bros Co., | Prime Resources Corp | Yuyao Jessie Commodity Co., Ltd
Effective date
2019-09-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:13:10

Label at a glance#

ProductPouch Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Take wipe and rub thoroughly over all surface of both hands Rub hands together briskly to dry. Dispose after single use. Do not flush

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

PL-1801 Label Template-backPL-1801 Label Template-backBenzalkonium chloride (0.13%)

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

for hand washing to decrease bacteria on skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from heat and flame.

Warnings

WARNINGS SECTION

For external use only.

Warnings

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water.

Warnings

OTC - STOP USE SECTION

Stop use & ask a doctor if irritation and redness develops and persists for more than 72 hours.

Warnings

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take wipe and rub thoroughly over all surface of both hands
  • Rub hands together briskly to dry.
  • Dispose after single use.
  • Do not flush

Directions

USER SAFETY WARNINGS SECTION

  • To start feed, discard seal, lift flap. pull wipe
  • from center,twist and thread through hole in
  • cap 1’’. Replace cover.
  • Keep cap closed to preven evaporation.
  • Always supervise children in use with this
  • product.
  • Throughly wipe hands; allow to dry without
  • rinsing.
  • Discard after single use.
  • Do not flush

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Chloromethylisothiazolinone& Methylisothiazolinone, Citric Acid,

Disodium Cocoamphodiacetate, Disodium EDTA, Fragrance, Polysorbate-20, Potassium Sorbate,

Propylene Glycol, Tocopheryl Acetate, Quaternium-15, Water.

Other information

OTHER SAFETY INFORMATION

may discolor certain fabrics

Questions?

OTC - QUESTIONS SECTION

1-800-873-7746 M-F 8am-5pm EST

OTHER SAFETY INFORMATION

PL-1801 BackPL-1801 BackUse by: XX/XXXX (Month/Year)

Lot no: AXXXXX (Batch Number)

Made in China

Distributed by: Prime Resource Corp Bridgeport, CT 06610

15 Anti-Bacterial Wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Each 7.5 in x 6.4 in (19cm x 16.25cm)1801 front1801 front

24 Antibacterial Wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24 Wipes EACH: 5.5 in. x 7.9 in. (14 cm x 20 cm) PL-1803PL-1803

50 Antibacterial Wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL-1802PL-1802

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71513-180-012022-11-28C16284748780-1c7ccaba7-198f-fd44-e053-dadaa90aa01b536d2665-9a7d-2d64-e054-00144ff88e88
71513-180-022022-11-28C16284748780-1c7ccaba7-198f-fd44-e053-dadaa90aa01b536d2665-9a7d-2d64-e054-00144ff88e88
71513-180-032022-11-28C16284748780-1c7ccaba7-198f-fd44-e053-dadaa90aa01b536d2665-9a7d-2d64-e054-00144ff88e88
71513-180-012021-07-23C16284748780-1c7ccaba7-198f-fd44-e053-dadaa90aa01b536d2665-9a7d-2d64-e054-00144ff88e88
71513-180-022021-07-23C16284748780-1c7ccaba7-198f-fd44-e053-dadaa90aa01b536d2665-9a7d-2d64-e054-00144ff88e88
71513-180-032021-07-23C16284748780-1c7ccaba7-198f-fd44-e053-dadaa90aa01b536d2665-9a7d-2d64-e054-00144ff88e88

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71513-18071513-180-11, 71513-180-01, 71513-180-22, 71513-180-02, 71513-180-33, 71513-180-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
QUATERNIUM-15E40U03LEM0IACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
ee8c1a2b-36f2-6fd7-e053-2a95a90a9c01536d2665-9a7d-2d64-e054-00144ff88e882022-11-28WarningsExact identifier
spl set id: 536d2665-9a7d-2d64-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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