FDA.reportPublic FDA data

Flushable wipes

Manufacturer
SVS, LLC (DBA S2S Global)
Effective date
2018-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:54:01

Label at a glance#

ProductFlushable wipes
Active ingredientDIMETHICONE
Label structure7 sections

Dosage and administration

peel back sticker clean affected area with wipe dispose of wipe properly reseal label

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 3.2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

provides temporary relief to irritated skin

Warning

WARNINGS SECTION

For external use only
Do not use on

Large cuts or wounds

severe burns

eyes or near mouth

stop use and call a doctor if

symptoms last for greater than 7 days or reoccur after clearing up

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children ,seek medical attention if swallowed

Directions

DOSAGE & ADMINISTRATION SECTION

peel back sticker

clean affected area with wipe

dispose of wipe properly

reseal label

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Aqua
Glycerin
Propylene Glycol
Polyaminopropyl Biguanide
Polysorbate 20
Allantoin
Chlorphenesin
Decyl Glucoside
2-Bromo-2-Nitropropane-1,3-Diol
Sodium Citrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69392-901-012020-01-31C16284748780-19d75b9d0-9c5e-f424-e053-dadaa90a57ce55c0f077-e365-1d95-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69392-901-01Flushable wipes24 in 1 CARTONGEL243
69392-901-01Flushable wipes290 g in 1 BAGGEL2903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69392-901FLUSHABLE WIPES (DIMETHICONE) GEL [SVS, LLC (DBA S2S GLOBAL)]3Legacy NDC, 2 package rows20180108_55c0f077-e365-1d95-e054-00144ff8d46c.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
69392-90169392-901-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
POLIHEXANIDE HYDROCHLORIDE4XI6112496IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CHLORPHENESINI670DAL4SZIACT
DIMETHICONE92RU3N3Y1OACTIB
BRONOPOL6PU1E16C9WIACT
POLYSORBATE 207T1F30V5YHIACT

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
621793d7-3fda-5379-e053-2a91aa0a11c855c0f077-e365-1d95-e054-00144ff8d46c2018-01-06WarningsExact identifier
spl id: 621793d7-3fda-5379-e053-2a91aa0a11c8
spl set id: 55c0f077-e365-1d95-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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