FDA.reportPublic FDA data

Safe and Silky Natural Hand Sanitizer

Manufacturer
CK Polymers LLC
Effective date
2020-10-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:13:10

Label at a glance#

ProductSafe and Silky Natural Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure5 sections

Label contents#

Full prescribing information#

Safe & Silky Fragrance Hand Sanitizer

SPL UNCLASSIFIED SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Benzalkonium chloride 0.13% 

Purpose

OTC - PURPOSE SECTION

Purpose: hand sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

Do not use in children less than 2 months of age or on open skin wounds.

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.

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

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, corn starch, soybean oil, petrolatum, pectin, xanthan gum, citricidal, tributyl phosphate, methyl paraben, propyl paraben, vitamin E acetate, white linen fragrance

INACTIVE INGREDIENT SECTION

Questions

55 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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330 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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5 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

1 Gallon Jug - Safe & Silky Fragrance Hand Sanitizer - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78235-007-012022-04-28C16284748780-1d6a99b39-61e0-a426-e053-dadaa90af4c2Safe & Silky Natural Hand Sanitizer
78235-007-022022-04-28C16284748780-1d6a99b39-61e0-a426-e053-dadaa90af4c2Safe & Silky Natural Hand Sanitizer
78235-007-032022-04-28C16284748780-1d6a99b39-61e0-a426-e053-dadaa90af4c2Safe & Silky Natural Hand Sanitizer
78235-007-042022-04-28C16284748780-1d6a99b39-61e0-a426-e053-dadaa90af4c2Safe & Silky Natural Hand Sanitizer
78235-007-012022-01-28C16284748780-1d6a99b39-61e0-a426-e053-dadaa90af4c2Safe & Silky Natural Hand Sanitizer
78235-007-022022-01-28C16284748780-1d6a99b39-61e0-a426-e053-dadaa90af4c2Safe & Silky Natural Hand Sanitizer
78235-007-032022-01-28C16284748780-1d6a99b39-61e0-a426-e053-dadaa90af4c2Safe & Silky Natural Hand Sanitizer
78235-007-042022-01-28C16284748780-1d6a99b39-61e0-a426-e053-dadaa90af4c2Safe & Silky Natural Hand Sanitizer

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
78235-00778235-007-01, 78235-007-02, 78235-007-03, 78235-007-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIEDQG4MW19XYXIACT
SOYBEAN OIL241ATL177AIACT
PETROLATUM4T6H12BN9UIACT
PECTIN89NA02M4RXIACT
XANTHAN GUMTTV12P4NEEIACT
GRAPEFRUIT SEED OIL598D944HOLIACT
TRIBUTYL PHOSPHITE498030B4ADIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
d16bbad3-df02-4b75-a91c-69d4f99e561e43a2c2f3-8930-44ab-a9e8-2e6ebd2f5f532022-04-28WarningsExact identifier
spl set id: 43a2c2f3-8930-44ab-a9e8-2e6ebd2f5f53

Reported adverse events (FAERS/openFDA)#

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