FDA.reportPublic FDA data

NAKED NATURALS HAND SANITIZER WITH VITAMIN E

Manufacturer
Welburn Corporation
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:57

Label at a glance#

ProductNAKED NATURALS HAND SANITIZER WITH VITAMIN E
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

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 ingestion.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that can potentially 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

OTC - DO NOT USE SECTION

  • On children less than 2 months of age.
  • On open skin wounds.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes, ears and mouth. In case of contact with eyes rinse thoroughly with water.

Stop use and seek a doctor

OTC - STOP USE SECTION

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

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

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 ingestion.

Other information

OTHER SAFETY INFORMATION

  • Store between 15-30C (59-86F).
  • Avoid freezing and excessive heat above 40C (104F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Tocopheryl Acetate, Blue 1 (CI 42090).

Questions?

OTC - QUESTIONS SECTION

call 888 387 3887

Company Information

SPL UNCLASSIFIED SECTION

Dist: Welburn Corporation

PO BOX 1392

Hermosa Beach, CA 90254

Made in Guatemala

Product Packaging - 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADVANCED FORMULA!

NAKED

NATURALS

HAND SANITIZER

WITH VITAMIN E

NON STERILE SOLUTION

ALCOHOL 70%

16.9 fl. oz. / 500ml

vitamin e sanitizervitamin e sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77622-007-012022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-022022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-032022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-042022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-052022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-062022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-072022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-082022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-092022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation
77622-007-102022-01-28C16284748780-1d6a99b39-dd9c-a426-e053-dadaa90af4c2Hand Sanitizer with Vitamin E - Welburn Corporation

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77622-007-01NAKED NATURALS HAND SANITIZER WITH VITAMIN E59 mL in 1 BOTTLE, PLASTICGEL591
77622-007-02NAKED NATURALS HAND SANITIZER WITH VITAMIN E118 mL in 1 BOTTLE, PLASTICGEL1181
77622-007-03NAKED NATURALS HAND SANITIZER WITH VITAMIN E280 mL in 1 BOTTLE, PLASTICGEL2801
77622-007-04NAKED NATURALS HAND SANITIZER WITH VITAMIN E236 mL in 1 BOTTLE, PLASTICGEL2361
77622-007-05NAKED NATURALS HAND SANITIZER WITH VITAMIN E458 mL in 1 BOTTLE, PLASTICGEL4581
77622-007-06NAKED NATURALS HAND SANITIZER WITH VITAMIN E1000 mL in 1 BOTTLE, PLASTICGEL10001
77622-007-07NAKED NATURALS HAND SANITIZER WITH VITAMIN E2000 mL in 1 BOTTLE, PLASTICGEL20001
77622-007-08NAKED NATURALS HAND SANITIZER WITH VITAMIN E3785 mL in 1 BOTTLE, PLASTICGEL37851
77622-007-09NAKED NATURALS HAND SANITIZER WITH VITAMIN E1000000 mL in 1 CONTAINERGEL10000001
77622-007-10NAKED NATURALS HAND SANITIZER WITH VITAMIN E500 mL in 1 BOTTLE, PLASTICGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77622-007NAKED NATURALS HAND SANITIZER WITH VITAMIN E (ALCOHOL) GEL [WELBURN CORPORATION]1Legacy NDC, 10 package rows20200703_a8fddcbd-84f9-1230-e053-2995a90aeede.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77622-00777622-007-01, 77622-007-02, 77622-007-04, 77622-007-03, 77622-007-05, 77622-007-06, 77622-007-07, 77622-007-08, 77622-007-09, 77622-007-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
a8fdcf74-e00b-483b-e053-2a95a90a8665a8fddcbd-84f9-1230-e053-2995a90aeede2020-06-25WarningsExact identifier
spl id: a8fdcf74-e00b-483b-e053-2a95a90a8665
spl set id: a8fddcbd-84f9-1230-e053-2995a90aeede

Reported adverse events (FAERS/openFDA)#

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