FDA.reportPublic FDA data

Antiseptic Wipes

Manufacturer
Flex Beauty Labs
Effective date
2020-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:44

Label at a glance#

ProductAntiseptic Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Adults and children over 2 yeas of age:Apply to hands. Allow to dry without wioing. Children under 2 year of age:ask doctor prior to use

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benalkonium chloride (0.13%)

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

Use to reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Do Not Use

OTC - DO NOT USE SECTION

Do not use if you are allegic to any of the ingredients.

When using this product 

OTC - WHEN USING SECTION

When using this product do not use in or near eyes.

In cases of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contqact a Poison Control Center right away

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 2 yeas of age:Apply to hands. Allow to dry without wioing.
  • Children under 2 year of age:ask doctor prior to use

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, sodium PCA,  Aloe barbadensis leaf juice, fragrance, polysorbate 20, tetrasodium EDTA, phenoxyethanol,  ethylhexylglycerin,  citric acid

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 WIPES

14 X 19 cm

5.5 IN X 7.4 IN

wips2wips2

20 WIPES

14 X 19 cm

5.5 IN X 7.4 IN

wips1wips1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72308-015-202022-01-28C16284748780-1d6a99b39-7620-a426-e053-dadaa90af4c2Germout- Wet Wipes Antibaterial
72308-015-602022-01-28C16284748780-1d6a99b39-7620-a426-e053-dadaa90af4c2Germout- Wet Wipes Antibaterial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72308-015-20Antiseptic Wipes20 in 1 PACKAGECLOTH201
72308-015-20Antiseptic Wipes1 mg in 1 PACKETCLOTH11
72308-015-60Antiseptic Wipes1 mg in 1 PACKETCLOTH11
72308-015-60Antiseptic Wipes60 in 1 PACKAGECLOTH601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72308-015ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [FLEX BEAUTY LABS]1Legacy NDC, 4 package rows20200624_7efa533b-7fa1-465d-8066-63669cdcea10.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72308-01572308-015-20, 72308-015-60

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 207T1F30V5YHIACT
EDETATE SODIUMMP1J8420LUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
a8cb25ac-a987-e64a-e053-2a95a90af8d57efa533b-7fa1-465d-8066-63669cdcea102020-06-23WarningsExact identifier
spl id: a8cb25ac-a987-e64a-e053-2a95a90af8d5
spl set id: 7efa533b-7fa1-465d-8066-63669cdcea10

Reported adverse events (FAERS/openFDA)#

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