FDA.reportPublic FDA data

Foaming Mousse Hand Sanitizer

Manufacturer
Accra Pac, Inc. (DBA KIK-Indiana)
Effective date
2020-04-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:21:32

Label at a glance#

ProductFoaming Mousse Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

To help decrease bact:eriafgerms on the sk!in that could cause disease. For use when soap and water are not available. Recommended for repeated use.

Dosage and administration

• Shake well before using. • Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer. • Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INSTRUCTIONS FOR USE SECTION

  • To help decrease bact:eriafgerms on the sk!in that could cause

disease. For use when soap and water are not available.

  • Recommended for repeated use.

Warnings

WARNINGS SECTION

Warnings
For external use only

• Do not puncture or incinerate.

• Do not store above 120°F (49°C).

When using this product

OTC - WHEN USING SECTION

• Avoid contact with eyes.
• It splashed in eyes, rinse immediately and thoroughly with water.
• Do not use on chil'dren under 2 months of age.
• Do not use on open wounds.
• Discontinue use if irritation/redness occurs.

Stop use and ask a physician

OTC - STOP USE SECTION

Stop use and ask a physician if irritation occurs for more than 3 days, contact a physician.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• In case of ingestion, get medical help or contact a Poison Control Center immediately.

Directions

INDICATIONS & USAGE SECTION

• Shake well before using.
• Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

• Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer.

Other Information

OTHER SAFETY INFORMATION

• For best benefit, store and use are 55-85° F (13-29°C).

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water, Hydrofluorocarbon 152a, lsobutane, Emulsifying Wax., Cetyl Lactate, Steareth-2, Sodium Benzoate, Sodium Sesquicarbonate.
Fragrance

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 mL NDC: 17630-3093-1

Paya®

HAND

SANITIZER

ANTISEPTIC

FOAM

62% v/v

Ethyl alcohol*

Fast-acting

No Rinsing!

Lightweight

formula

*Non-Sterile Solution.

Net Wt: 7 oz (200g)

41801PB label_V241801PB label_V2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616763ethanol 62 % Topical FoamPSN4
616763ethanol 0.62 ML/ML Topical FoamSCD4
616763ethanol 62 % Topical FoamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17630-3093-12024-01-30C16284748780-11030e365-5528-111a-e063-dadaa90a10e2Paya® Hand Sanitizer Antiseptic Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17630-3093-1Foaming Mousse Hand Sanitizer1 mL in 1 BOTTLEAEROSOL, FOAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17630-3093FOAMING MOUSSE HAND SANITIZER (ALCOHOL) AEROSOL, FOAM [ACCRA PAC, INC. (DBA KIK-INDIANA)]4Legacy NDC, 1 package rows20200716_a128db0c-6911-c387-e053-2995a90a3de8.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17630-309317630-3093-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
a2e12c47-0f81-6f7f-e053-2995a90a3161a128db0c-6911-c387-e053-2995a90a3de82020-04-10WarningsExact identifier
spl id: a2e12c47-0f81-6f7f-e053-2995a90a3161
spl set id: a128db0c-6911-c387-e053-2995a90a3de8

Reported adverse events (FAERS/openFDA)#

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