FDA.reportPublic FDA data

MANI SPA GUARD ADVANCED HAND SANITIZER

Manufacturer
Pedisource
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:52

Label at a glance#

ProductMANI SPA GUARD ADVANCED HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame
For external use only

Do not use• in children less than 2 months of age
• on open skin wounds

When using this product • do not get into eyes. In case of
contact, rinse eyes thoroughly with water

Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours

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

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, aloe barbadensis leaf juice, tocopheryl acetate, polyacrylate crosspolymer, fragrance

Questions?

OTC - QUESTIONS SECTION

+1-856-320-6927
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

MADE IN * * * THE USA

• ALCOHOL 70% • GEL FORMULA

• WITH ALOE VERA & VITAMIN E

Manufactured by: PediSource LLC, Cinnaminson, NJ, 08077
www.ManiSpaGuard.co m

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

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
77591-002-022022-01-28C16284748780-1d6a99b39-5b6b-a426-e053-dadaa90af4c2MANI SPA GUARD TM ADVANCED HAND SANITIZER
77591-002-042022-01-28C16284748780-1d6a99b39-5b6b-a426-e053-dadaa90af4c2MANI SPA GUARD TM ADVANCED HAND SANITIZER
77591-002-072022-01-28C16284748780-1d6a99b39-5b6b-a426-e053-dadaa90af4c2MANI SPA GUARD TM ADVANCED HAND SANITIZER
77591-002-082022-01-28C16284748780-1d6a99b39-5b6b-a426-e053-dadaa90af4c2MANI SPA GUARD TM ADVANCED HAND SANITIZER
77591-002-162022-01-28C16284748780-1d6a99b39-5b6b-a426-e053-dadaa90af4c2MANI SPA GUARD TM ADVANCED HAND SANITIZER
77591-002-322022-01-28C16284748780-1d6a99b39-5b6b-a426-e053-dadaa90af4c2MANI SPA GUARD TM ADVANCED HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77591-002-02MANI SPA GUARD ADVANCED HAND SANITIZER59 mL in 1 BOTTLE, PLASTICGEL591
77591-002-04MANI SPA GUARD ADVANCED HAND SANITIZER118 mL in 1 BOTTLE, PLASTICGEL1181
77591-002-07MANI SPA GUARD ADVANCED HAND SANITIZER3785 mL in 1 BOTTLE, PLASTICGEL37851
77591-002-08MANI SPA GUARD ADVANCED HAND SANITIZER237 mL in 1 BOTTLE, PLASTICGEL2371
77591-002-16MANI SPA GUARD ADVANCED HAND SANITIZER473 mL in 1 BOTTLE, PLASTICGEL4731
77591-002-32MANI SPA GUARD ADVANCED HAND SANITIZER946 mL in 1 BOTTLE, PLASTICGEL9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77591-002MANI SPA GUARD ADVANCED HAND SANITIZER (ALCOHOL) GEL [PEDISOURCE]1Legacy NDC, 6 package rows20200625_596df770-9bc1-4094-b4df-ad4c2dc2d89f.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
77591-00277591-002-02, 77591-002-04, 77591-002-08, 77591-002-16, 77591-002-32, 77591-002-07

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT

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
5b31192f-0bd1-4154-8755-f5e6f3d0d0f7596df770-9bc1-4094-b4df-ad4c2dc2d89f2020-05-28WarningsExact identifier
spl id: 5b31192f-0bd1-4154-8755-f5e6f3d0d0f7
spl set id: 596df770-9bc1-4094-b4df-ad4c2dc2d89f

Reported adverse events (FAERS/openFDA)#

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