MANI SPA GUARD ANTISEPTIC HAND SANITIZER

Manufacturer
Pedisource
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:43

Label at a glance#

ProductMANI SPA GUARD ANTISEPTIC 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 80% 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

glycerin, hydrogen peroxide, water

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

TOPICAL SOLUTION

NON-STERILE SOLUTION

Manufactured by: PediSource LLC, Cinnaminson, NJ, 08077

www.ManiSpaGuard.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77591-001-05MANI SPA GUARD ANTISEPTIC HAND SANITIZER118 mL in 1 BOTTLE, PLASTICSOLUTION1181
77591-001-06MANI SPA GUARD ANTISEPTIC HAND SANITIZER473 mL in 1 BOTTLE, PLASTICSOLUTION4731
77591-001-07MANI SPA GUARD ANTISEPTIC HAND SANITIZER3785 mL in 1 BOTTLE, PLASTICSOLUTION37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77591-001MANI SPA GUARD ANTISEPTIC HAND SANITIZER (ALCOHOL) SOLUTION [PEDISOURCE]1Legacy NDC, 3 package rows20200603_72f782fa-5db0-4326-8812-dede84c05596.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77591-00177591-001-05, 77591-001-06, 77591-001-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
b5fcdd3f-7b59-4d73-9a00-2c41839e11ac72f782fa-5db0-4326-8812-dede84c055962020-05-12WarningsExact identifier
spl id: b5fcdd3f-7b59-4d73-9a00-2c41839e11ac
spl set id: 72f782fa-5db0-4326-8812-dede84c05596

Reported adverse events (FAERS/openFDA)#

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