FDA.reportPublic FDA data

Pure Care Hand Sanitizer

Manufacturer
Zhejiang Yiwu Limei Cosmetics Co., Ltd
Effective date
2020-05-13
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 23:11:14

Label at a glance#

ProductPure Care Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

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 swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NA

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

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 heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

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 or rash occurs. These may be signs of a serious condition.
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 or rash occurs. These may be signs of a serious condition.

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

  • 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 swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water,propylene glycol, glycerin, carbomer, triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 74765-010-01

150 mL NDC: 74765-010-02

236 mL NDC: 74765-010-03 236ml236ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN11
581662ethanol 0.7 ML/ML Topical GelSCD11
581662ethanol 70 % Topical GelSY11
581662ethyl alcohol 70 % Topical GelSY11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74765-010-012022-01-28C16284748780-1d6a99b39-f27f-a426-e053-dadaa90af4c2a4e30e68-7cea-b852-e053-2995a90a91c9
74765-010-022022-01-28C16284748780-1d6a99b39-f27f-a426-e053-dadaa90af4c2a4e30e68-7cea-b852-e053-2995a90a91c9
74765-010-032022-01-28C16284748780-1d6a99b39-f27f-a426-e053-dadaa90af4c2a4e30e68-7cea-b852-e053-2995a90a91c9
74765-010-042022-01-28C16284748780-1d6a99b39-f27f-a426-e053-dadaa90af4c2a4e30e68-7cea-b852-e053-2995a90a91c9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74765-010-01Pure Care Hand Sanitizer60 mL in 1 BOTTLEGEL6011
74765-010-02Pure Care Hand Sanitizer150 mL in 1 BOTTLEGEL15011
74765-010-03Pure Care Hand Sanitizer236 mL in 1 BOTTLEGEL23611
74765-010-04Pure Care Hand Sanitizer500 mL in 1 BOTTLEGEL50011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74765-010PURE CARE HAND SANITIZER (ALCOHOL) GEL [ZHEJIANG YIWU LIMEI COSMETICS CO., LTD]11Legacy NDC, 4 package rows20200514_a4e30e68-7cea-b852-e053-2995a90a91c9.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74765-01074765-010-01, 74765-010-02, 74765-010-03, 74765-010-04

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
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9804Q93RCW27EIACT

Source Document#

Source XML · Source PDF

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
a583d72d-40dd-4d5e-e053-2995a90abdd4a4e30e68-7cea-b852-e053-2995a90a91c92020-05-13WarningsExact identifier
spl id: a583d72d-40dd-4d5e-e053-2995a90abdd4
spl set id: a4e30e68-7cea-b852-e053-2995a90a91c9

Reported adverse events (FAERS/openFDA)#

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