FDA.reportPublic FDA data

BabingtonSoapCo

Manufacturer
Babington Soap Co Limited | George K Hood Legacy LLP
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:33

Label at a glance#

ProductBabingtonSoapCo
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Dispense onto dry hands and rub together thoroughly and then allow product to dry without rinsing. Do not use on open skin or wounds. Not for use by children under 6 years old.

Storage and handling

Do not store above 106F. If skin irritation or rash occurs discontinue use immediately. May discolor some fabrics.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 66% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame

For external use only.

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 and redness develop.

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 and redness develop.

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

  • Dispense onto dry hands and rub together thoroughly and then allow product to dry without rinsing. Do not use on open skin or wounds.
  • Not for use by children under 6 years old.

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 106F.
  • If skin irritation or rash occurs discontinue use immediately.
  • May discolor some fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Polyquaternium 10, Chitosan, lactic acid organic, lemongrass oil.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55 mL NDC: 80104-111-1155 mL NDC: 80104-111-1155 mL NDC: 80104-111-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039811ethanol 66 % Topical GelPSN2
1039811ethanol 0.66 ML/ML Topical GelSCD2
1039811ethanol 66 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80104-111-112022-01-28C16284748780-1d6a99b39-7fc7-a426-e053-dadaa90af4c2Babington Soap Co. 55ML
80104-111-122022-01-28C16284748780-1d6a99b39-7fc7-a426-e053-dadaa90af4c2Babington Soap Co. 55ML

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80104-111-11BabingtonSoapCo55 mL in 1 BOTTLEGEL552
80104-111-12BabingtonSoapCo250 mL in 1 BOTTLEGEL2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80104-111BABINGTONSOAPCO (HAND SANITIZER GEL) GEL [BABINGTON SOAP CO LIMITED]2Legacy NDC, 2 package rows20201203_b57e6737-5166-3c42-e053-2a95a90a9db6.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80104-11180104-111-11, 80104-111-12

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
POLYQUATERNIUM-10 (20000 MPA.S AT 2%)N2GK4S7X4TIACT
CYMBOPOGON SCHOENANTHUS OILXE7K568ILOIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
LACTIC ACID33X04XA5ATIACT
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)5GV09YMO52IACT

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
b57f812d-86c6-691e-e053-2a95a90adff4b57e6737-5166-3c42-e053-2a95a90a9db62020-12-02WarningsExact identifier
spl id: b57f812d-86c6-691e-e053-2a95a90adff4
spl set id: b57e6737-5166-3c42-e053-2a95a90a9db6

Reported adverse events (FAERS/openFDA)#

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