FDA.reportPublic FDA data

Terra Pure Spa Collection Fresh Aloe Hand Sanitizer

Manufacturer
Yangzhou Eco-Amenities CO., Ltd
Effective date
2020-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:48

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Ethanol (Alcohol)69% v/v

Uses

Use

hand sanitizer to help reduce bacteria on the skin

Warnings

Warnings

for external use only: hands

Directions And Dosage

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use only under adult supervision.

Other Label Information

Inactive Ingredients

Water, Dichlorobenzyl alcohol, Acrylates/C10-30 alkyl acrylate crosspolymer, Triethanolamine, Methyl Gluceth-20, Glycerin, Organic Aloe Barbadensis Leaf Juice, Tocopherol, Fragrance, FD&C Yellow No.5, FD&C Blue No.1

Package Labeling:

Label Images#

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287763ethanol 69 % Topical GelPSN1
2287763ethanol 0.69 ML/ML Topical GelSCD1
2287763ethanol 69 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77849-005-012022-01-28C16284748780-1d6a99b39-c7b9-a426-e053-dadaa90af4c2Terra Pure Spa Collection Fresh Aloe Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77849-005-01Terra Pure Spa Collection Fresh Aloe Hand Sanitizer50 mL in 1 BOTTLEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77849-005TERRA PURE SPA COLLECTION FRESH ALOE HAND SANITIZER (ALCOHOL) GEL [YANGZHOU ECO-AMENITIES CO., LTD]1Legacy NDC, 1 package rows20200815_acdb3a7d-4159-e823-e053-2995a90a654c.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77849-00577849-005-01

Ingredients#

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DICHLOROBENZYL ALCOHOL1NKX3648J9IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
METHYL GLUCETH-20J3QD0LD11PIACT
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol (Alcohol)69% v/v

Use

INDICATIONS & USAGE SECTION

hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

for external use only: hands

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use only under adult supervision.

Other information

SPL UNCLASSIFIED SECTION

Store between 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (140°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dichlorobenzyl alcohol, Acrylates/C10-30 alkyl acrylate crosspolymer, Triethanolamine, Methyl Gluceth-20, Glycerin, Organic Aloe Barbadensis Leaf Juice, Tocopherol, Fragrance, FD&C Yellow No.5, FD&C Blue No.1

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML