FDA.reportPublic FDA data

AG LINEA HAND SANITIZER

Manufacturer
Natural Dyes Inc | Taizhou Huangyan Liweir Cosmetic Technology LTD | Sanrace Biotechnology Co., Ltd.
Effective date
2020-08-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:33

Label at a glance#

ProductAG LINEA HAND SANITIZER
Active ingredientAlcohol
Label structure9 sections

Indications and uses

To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.

Dosage and administration

• Wet hand thoroughly with product and allow to dry without wiping. • No rinsing required. • For children under 6, use only under adult supervision. • Not recommended for infants.

Storage and handling

• Store below 105˚F(40˚C). • May discolor certain fabrics. • Harmful to wood finishes & plastics

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • To decrease bacteria on the skin that could cause disease.
  • When water, soap and towel are not available.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only: hands.

Flammable. Keep away from fire or flame.

When using this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

Stop use and ask a doctor if • redness or irritation develop

• condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Children should be supervised by an adult when using this product. • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hand thoroughly with product and allow to dry without wiping. • No rinsing required. • For children under 6, use only under adult supervision. • Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

• Store below 105˚F(40˚C). • May discolor certain fabrics. • Harmful to wood finishes & plastics

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water(Aqua), Triethanolamine, Carbomer, Aloe Barbadensis(Aloe Vera) Gel, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate(Vitamin E).

SPL UNCLASSIFIED SECTION

Distributed by:

Natural Dyes Inc.

New York, NY 10018

Made in China

UPC CODE

Kills 99.9% of Germs

ADVANCED MOISTURIZING FORMULA WITH ALOE AND VITAMIN E

HOW TO USE HAND SANITIZER

Dispense a coin sized drop of sanitizer on your palm.

Spread the sanitizer and rub palms together.

Rub sanitizer on palms, between fingers, finger tips, and back of hands.

Rub hands together for 20 seconds until sanitizer dries.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77781-001-012022-01-28C16284748780-1d6a99b39-e02d-a426-e053-dadaa90af4c2AG LINEA HAND SANITIZER
77781-001-032022-01-28C16284748780-1d6a99b39-e02d-a426-e053-dadaa90af4c2AG LINEA HAND SANITIZER
77781-001-042022-01-28C16284748780-1d6a99b39-e02d-a426-e053-dadaa90af4c2AG LINEA HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77781-001-01AG LINEA HAND SANITIZER237 mL in 1 BOTTLEGEL2372
77781-001-03AG LINEA HAND SANITIZER500 mL in 1 BOTTLEGEL5002
77781-001-04AG LINEA HAND SANITIZER60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77781-001AG LINEA HAND SANITIZER (ETHYL ALCOHOL) GEL [NATURAL DYES INC]2Legacy NDC, 3 package rows20200813_82ff206d-2287-482c-89b1-8d09aa5a6a58.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
77781-00177781-001-04, 77781-001-01, 77781-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.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
4e78898a-e1e4-45fe-8d14-a3c630b6f31582ff206d-2287-482c-89b1-8d09aa5a6a582020-08-11WarningsExact identifier
spl id: 4e78898a-e1e4-45fe-8d14-a3c630b6f315
spl set id: 82ff206d-2287-482c-89b1-8d09aa5a6a58

Reported adverse events (FAERS/openFDA)#

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