FDA.reportPublic FDA data

Real Time Hand Sanitizer 70% Alcohol

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2020-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:12

Label at a glance#

ProductReal Time Hand Sanitizer 70% Alcohol
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

• Use enough product in your palm to cover hands and rub hands together briskly until dry. • Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Flammable - Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash appears and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Use enough product in your palm to cover
hands and rub hands together briskly until dry.
• Children under 6 years of age should be
supervised when using this product.

Other information

OTHER SAFETY INFORMATION

  • Do not store above 110°F (43°C)
  • May discolor fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice,
Butylene Glycol, C13-14 Isoparaffin, Caprylyl Glycol,
Chamomilla recutita (Matricaria) Flower Extract,
Glycerin, Laureth-7, Phenoxyethanol,
Polyacrylamide, Purified Water, Tocopheryl Acetate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

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
58133-957-032024-01-30C16284748780-11030e365-3c2c-111a-e063-dadaa90a10e2Real Time Hand Sanitizer
58133-957-042024-01-30C16284748780-11030e365-3c2c-111a-e063-dadaa90a10e2Real Time Hand Sanitizer
58133-957-122024-01-30C16284748780-11030e365-3c2c-111a-e063-dadaa90a10e2Real Time Hand Sanitizer
58133-957-152024-01-30C16284748780-11030e365-3c2c-111a-e063-dadaa90a10e2Real Time Hand Sanitizer
58133-957-162024-01-30C16284748780-11030e365-3c2c-111a-e063-dadaa90a10e2Real Time Hand Sanitizer
58133-957-282024-01-30C16284748780-11030e365-3c2c-111a-e063-dadaa90a10e2Real Time Hand Sanitizer
58133-957-402024-01-30C16284748780-11030e365-3c2c-111a-e063-dadaa90a10e2Real Time Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-957-03Real Time Hand Sanitizer 70% Alcohol89 mL in 1 BOTTLEGEL891
58133-957-04Real Time Hand Sanitizer 70% Alcohol118 mL in 1 BOTTLEGEL1181
58133-957-12Real Time Hand Sanitizer 70% Alcohol355 mL in 1 BOTTLEGEL3551
58133-957-15Real Time Hand Sanitizer 70% Alcohol44 mL in 1 BOTTLEGEL441
58133-957-16Real Time Hand Sanitizer 70% Alcohol474 mL in 1 BOTTLEGEL4741
58133-957-28Real Time Hand Sanitizer 70% Alcohol3789 mL in 1 BOTTLEGEL37891
58133-957-40Real Time Hand Sanitizer 70% Alcohol400 mL in 1 BOTTLEGEL4001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-957REAL TIME HAND SANITIZER 70% ALCOHOL (ALCOHOL HAND SANITIZER) GEL [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 7 package rows20200714_aa529cba-8ded-11c6-e053-2995a90afe04.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-95758133-957-15, 58133-957-03, 58133-957-04, 58133-957-12, 58133-957-40, 58133-957-16, 58133-957-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
C13-14 ISOPARAFFINE4F12ROE70IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
LAURETH-7Z95S6G8201IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
aa5280a9-d306-7d6e-e053-2a95a90a44c3aa529cba-8ded-11c6-e053-2995a90afe042020-07-13WarningsExact identifier
spl id: aa5280a9-d306-7d6e-e053-2a95a90a44c3
spl set id: aa529cba-8ded-11c6-e053-2995a90afe04

Reported adverse events (FAERS/openFDA)#

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