FDA.reportPublic FDA data

Refill 6

Manufacturer
CMC Group, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:52:35

Label at a glance#

ProductRefill 6
Active ingredientALCOHOL, WATER
Label structure15 sections

Indications and uses

For handwashing to decrease bacteria on the skin Recommended for repeated use.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flameFor external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach 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

  • Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, propylene glycol, purified water, titanium dioxide

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified Water 99.1%

Purpose

OTC - PURPOSE SECTION

Eyewash

Use

INDICATIONS & USAGE SECTION

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

WARNINGS AND PRECAUTIONS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

if solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

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

• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Other information

SPL UNCLASSIFIED SECTION

• not for use as contact lens solution

• use before expiration date marked on the bottle

• store at room temperature, 5° to 35°C (41° to 95°F)

Inactive ingredients

SPL UNCLASSIFIED SECTION

Benzalkonium chloride, sodium chloride

Hand Sanitizer (49687-0015-0) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand sanitizerHand sanitizer

Eye Wash (50814-010-01) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eye washEye wash

Refill 6 (49687-0019-0) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Refill 6Refill 6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN11
1053429water 99.1 % Ophthalmic Irrigation SolutionPSN11
581660ethanol 0.62 ML/ML Topical GelSCD11
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCD11
581660ethanol 62 % Topical GelSY11
1053429water 99.05 % Ophthalmic Irrigation SolutionSY11
1053429water 99.1 % Ophthalmic Irrigation SolutionSY11
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSY11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49687-0019-02020-02-04C16284748780-19d75b9cf-ebe5-f424-e053-dadaa90a57ceRefill 6
49687-0019-02020-01-31C16284748780-19d75b9cf-ebe5-f424-e053-dadaa90a57ceRefill 6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0010-1Refill 630 mL in 1 TUBESOLUTION30 mL991 mg in 1mL11
49687-0010-1Refill 61 in 1 BOXSOLUTION991 mg in 1mL11
49687-0015-0Refill 60.9 g in 1 BOTTLEGEL5.4 g0.62 g in 1g11
49687-0015-0Refill 66 in 1 KITGEL0.62 g in 1g11
49687-0019-0Refill 61 in 1 KITKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0010REFILL 6 (ALCOHOL, WATER) KIT [CMC GROUP, INC.]11Current NDC, Legacy NDC20250115_7849ae59-5484-4b86-a0b9-ec9b93d9afe0.zip
49687-0015REFILL 6 (ALCOHOL, WATER) KIT [CMC GROUP, INC.]11Current NDC, Legacy NDC20250115_7849ae59-5484-4b86-a0b9-ec9b93d9afe0.zip
49687-0019REFILL 6 (ALCOHOL, WATER) KIT [CMC GROUP, INC.]11Current NDC, Legacy NDC, 5 package rows20250115_7849ae59-5484-4b86-a0b9-ec9b93d9afe0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49687-001949687-0019-0
49687-001549687-0015-0
49687-001049687-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALCOHOL3K9958V90MACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RACTIB

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
ndc (package): 49687-0010-1
ndc (product): 49687-0010
ndc11 (package): 49687001001
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
ndc (package): 49687-0010-1
ndc11 (package): 49687001001
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
ndc (package): 49687-0010-1
ndc11 (package): 49687001001
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
ndc (package): 49687-0015-0
ndc (product): 49687-0015
ndc11 (package): 49687001500
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
ndc (package): 49687-0010-1
ndc (package): 49687-0019-0
ndc (package): 49687-0015-0
ndc (product): 49687-0019
ndc11 (package): 49687001001
ndc11 (package): 49687001900
ndc11 (package): 49687001500
spl id: 2ba1a752-8549-47e2-e063-6394a90a54d5
spl set id: 7849ae59-5484-4b86-a0b9-ec9b93d9afe0

Reported adverse events (FAERS/openFDA)#

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