FDA.reportPublic FDA data

Sani Kare

Manufacturer
Beaming White LLC
Effective date
2022-01-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:11:12

Label at a glance#

ProductSani Kare
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Dispense a small amount onto palm of hand and rub briskly and thoroughly over surfaces of both hands until dry. Children under 6 years of age should be supervised while using this product.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 68% v/v. Purpose: Antiseptic

LABELLABEL

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to reduce bacterial organisms on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, flush 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 or rash develops and persists.

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

  • Dispense a small amount onto palm of hand and rub briskly and thoroughly over surfaces of both hands until dry.
  • Children under 6 years of age should be supervised while using this product.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Eucalyptus Oil, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75669-0111-12022-01-30C16284748780-1d6a99b39-608e-a426-e053-dadaa90af4c2SANI KARE Eucalptus
75669-0111-12022-01-28C16284748780-1d6a99b39-608e-a426-e053-dadaa90af4c2SANI KARE Eucalptus

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75669-011175669-0111-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
EUCALYPTUS OIL2R04ONI662IACT

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
d6ad70f7-88aa-39c8-e053-2995a90ae4acaa84f161-cce3-d21d-e053-2995a90a45502022-01-28WarningsExact identifier
spl id: d6ad70f7-88aa-39c8-e053-2995a90ae4ac
spl set id: aa84f161-cce3-d21d-e053-2995a90a4550

Reported adverse events (FAERS/openFDA)#

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