FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
BBC GROUP LIMITED
Effective date
2020-09-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:29:06

Label at a glance#

ProductHand Sanitizer with Vitamin E
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

■ to decrease bacteria on the skin that could cause disease ■ recommended for repeated use

Dosage and administration

■ wet hands thoroughly with product and allow to dry without wiping ■ for children under 6, use only under adult supervision ■ not recommended for infants

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat. 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ to decrease bacteria on the skin that could cause disease ■ recommended for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

■ keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ avoid contact with broken skin ■ do not inhale or ingest

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ irritation and redness develop ■ condition persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ wet hands thoroughly with product and allow to dry without wiping ■ for children under 6, use only under adult supervision ■ not recommended for infants

Other information

SPL UNCLASSIFIED SECTION

■ do not store above 105ºF ■ may discolor some fabrics ■ harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, PEG-40 Hydrogenated Castor Oil, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Denatonium Benzoate, Tocopheryl Acetate

Questions?

OTC - QUESTIONS SECTION

1-888-287-1915

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN4
247835ethanol 0.62 ML/ML Topical SolutionSCD4
247835ethanol 62 % Topical SolutionSY4
247835ethyl alcohol 62 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76383-014-012022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-022022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-032022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-082022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-122022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-162022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-282022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-302022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-342022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE
76383-014-502022-01-28C16284748780-1d6a99b39-c8e6-a426-e053-dadaa90af4c2Hand Sanitizer with VitE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76383-014-01Hand Sanitizerwith Vitamin E50 mL in 1 BOTTLE, PLASTICLIQUID504
76383-014-02Hand Sanitizerwith Vitamin E30 mL in 1 BOTTLE, PLASTICLIQUID304
76383-014-03Hand Sanitizerwith Vitamin E89 mL in 1 BOTTLE, PLASTICLIQUID894
76383-014-07Hand Sanitizerwith Vitamin E2 mL in 1 PACKETLIQUID24
76383-014-08Hand Sanitizerwith Vitamin E236 mL in 1 BOTTLE, PLASTICLIQUID2364
76383-014-12Hand Sanitizerwith Vitamin E354 mL in 1 BOTTLE, PUMPLIQUID3544
76383-014-16Hand Sanitizerwith Vitamin E473 mL in 1 BOTTLE, PLASTICLIQUID4734
76383-014-28Hand Sanitizerwith Vitamin E3789 mL in 1 BOTTLE, PLASTICLIQUID37894
76383-014-30Hand Sanitizerwith Vitamin E887 mL in 1 BOTTLE, PUMPLIQUID8874
76383-014-34Hand Sanitizerwith Vitamin E1000 mL in 1 BOTTLE, PUMPLIQUID10004
76383-014-50Hand Sanitizerwith Vitamin E50 in 1 BOXLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76383-014HAND SANITIZER WITH VITAMIN E (ALCOHOL) LIQUID [BBC GROUP LIMITED]4Legacy NDC, 11 package rows20200912_a7945852-99c4-1287-e053-2a95a90a7914.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
76383-01476383-014-01, 76383-014-03, 76383-014-08, 76383-014-12, 76383-014-30, 76383-014-34, 76383-014-28, 76383-014-02, 76383-014-16, 76383-014-07, 76383-014-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MACTIB

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
af10299d-c9aa-7726-e053-2995a90a8163a7945852-99c4-1287-e053-2a95a90a79142020-09-11WarningsExact identifier
spl id: af10299d-c9aa-7726-e053-2995a90a8163
spl set id: a7945852-99c4-1287-e053-2a95a90a7914

Reported adverse events (FAERS/openFDA)#

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