FDA.reportPublic FDA data

DISINFECTING WIPES

Manufacturer
Tmd Holdings, Llc | Fuan Huh Bio Tech co.,Ltd | Zhangzhou KangBei Hyginenic Products Co.,Ltd | ZHEJIANG BINGER NONWOVEN CO., LTD.
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:58

Label at a glance#

ProductDISINFECTING WIPES
Active ingredientBENZALKONIUM CHLORIDE, DIDECYLDIMONIUM CHLORIDE
Label structure12 sections

Dosage and administration

For use apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash after use. Do not flush. For dispensing flip open dispensing cap and remove entire lid from canister by lifting upward. Locate wipe at center of roll, twist corner to a point and thread through small opening in lid. DO NOT PUSH FINGER THROUGH OPENING. Replace lid and pull sheet up at an angle. Remaining wipes feed auto...

Storage and handling

Store below 110F(43C) May discolor certain fabrics.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.184% w/w, Purspose: Antimicrobial

Didecyldimonium Chloride 0.2% w/w, Purspose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For hand washing to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • 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 develops and persists for more than 72 hours.

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

  • For use apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash after use. Do not flush.
  • For dispensing flip open dispensing cap and remove entire lid from canister by lifting upward.
  • Locate wipe at center of roll, twist corner to a point and thread through small opening in lid.
  • DO NOT PUSH FINGER THROUGH OPENING.
  • Replace lid and pull sheet up at an angle. Remaining wipes feed automatically.
  • When finished, snap lid cap shut to retain moisture.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F(43C)
  • May discolor certain fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethylhexylglycerin, Glycerin, Fragrance(Parfum), Phenoxyethanol, Propylene Glycol, Purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160 Wipes NDC: 80297-031-01 Package LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80297-031-012021-07-23C16284748780-1c7ccaba7-1923-fd44-e053-dadaa90aa01badc424a2-725e-3eef-e053-2995a90ac3b9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80297-031-01DISINFECTING WIPES1050 g in 1 PAILCLOTH10501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80297-031DISINFECTING WIPES (HAND SANITIZER) CLOTH [TMD HOLDINGS, LLC]1Legacy NDC, 1 package rows20200827_adc424a2-725e-3eef-e053-2995a90ac3b9.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80297-03180297-031-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BACTIB
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT

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
adc40600-e4c2-9784-e053-2995a90af5c4adc424a2-725e-3eef-e053-2995a90ac3b92020-08-26WarningsExact identifier
spl id: adc40600-e4c2-9784-e053-2995a90af5c4
spl set id: adc424a2-725e-3eef-e053-2995a90ac3b9

Reported adverse events (FAERS/openFDA)#

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