FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Junior Chemical Products Care S.A. de C.V.
Effective date
2020-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:03

Label at a glance#

ProductHand 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

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Glycerin (1.45% v/v).

Triethanolamine capryol glutamate (0.12% v/v).

Sterile distilled water or boiled cold water.

Carbomer 980 (0.86% v/v)

Aloe vera leaf (0.02% v/v)

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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.

Use

INDICATIONS & USAGE SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 - 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.

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

glycerin, carbomer, triethanolamine caproyl glutamato, aloe vera leaf, purified water USP

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.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000000 mL NDC 78359-001-08 1000000ml1000000ml 250 ml250 ml

200000ml200000ml3780ml3780ml

1000ml1000ml500ml500ml125ml125mlpacking 60mlpacking 60ml

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
78359-001-012022-01-28C16284748780-1d6a99b39-f6ca-a426-e053-dadaa90af4c2Hand Sanitizer
78359-001-022022-01-28C16284748780-1d6a99b39-f6ca-a426-e053-dadaa90af4c2Hand Sanitizer
78359-001-032022-01-28C16284748780-1d6a99b39-f6ca-a426-e053-dadaa90af4c2Hand Sanitizer
78359-001-042022-01-28C16284748780-1d6a99b39-f6ca-a426-e053-dadaa90af4c2Hand Sanitizer
78359-001-052022-01-28C16284748780-1d6a99b39-f6ca-a426-e053-dadaa90af4c2Hand Sanitizer
78359-001-062022-01-28C16284748780-1d6a99b39-f6ca-a426-e053-dadaa90af4c2Hand Sanitizer
78359-001-072022-01-28C16284748780-1d6a99b39-f6ca-a426-e053-dadaa90af4c2Hand Sanitizer
78359-001-082022-01-28C16284748780-1d6a99b39-f6ca-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78359-001-01Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
78359-001-02Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78359-001-03Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICGEL37801
78359-001-04Hand Sanitizer200000 mL in 1 DRUMGEL2000001
78359-001-05Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL601
78359-001-06Hand Sanitizer125 mL in 1 BOTTLE, PLASTICGEL1251
78359-001-07Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
78359-001-08Hand Sanitizer1000000 mL in 1 DRUMGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78359-001HAND SANITIZER (ALCOHOL) GEL [JUNIOR CHEMICAL PRODUCTS CARE S.A. DE C.V.]1Legacy NDC, 8 package rows20200626_a67cac96-b8bd-9882-e053-2995a90a25a5.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
78359-00178359-001-01, 78359-001-02, 78359-001-03, 78359-001-04, 78359-001-05, 78359-001-06, 78359-001-07, 78359-001-08

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
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TRIETHANOLAMINE CAPROYL GLUTAMATE0F2FO57253IACT
CARBOMER 9804Q93RCW27EIACT
ALOE VERA LEAF POLYSACCHARIDESW21O437517IACT

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
a67ca128-3de5-4219-e053-2995a90aa35aa67cac96-b8bd-9882-e053-2995a90a25a52020-05-25WarningsExact identifier
spl id: a67ca128-3de5-4219-e053-2995a90aa35a
spl set id: a67cac96-b8bd-9882-e053-2995a90a25a5

Reported adverse events (FAERS/openFDA)#

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