FDA.reportPublic FDA data

Certus Recens A

Manufacturer
Certus Medical, Inc. | ABC Compounding Co., Inc. | ABC Compounding Company of Texas, Inc.
Effective date
2018-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:45:43

Label at a glance#

ProductCertus Recens A
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

for hand-washing to decrease bacteria on the skin, only when water is not available

Label contents#

Full prescribing information#

Drug Facts Box OTC-Active Ingredients Section

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

OTC - PURPOSE SECTION

Antiseptic

Drug Facts Box OTC-Indications and Usage Section

INDICATIONS & USAGE SECTION

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

WARNINGS SECTION

Flammable, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

OTC - WHEN USING SECTION

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

OTC - STOP USE SECTION

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Drug Facts Box OTC-Dosage & Administration Section

DOSAGE & ADMINISTRATION SECTION

press valve once to deliver one squirt (about a quarter size) of foaming product onto the palm of your hand

rub hands together and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredients Section

INACTIVE INGREDIENT SECTION

water, DEA-C8-18 perfluoroalkylethyl phosphate, cetearyl alcohol, polysorbate 60, polysorbate 65, dimethicone PEG-8 meadowfoamate, meadowfoamamidopropyl betaine, stearth 20, PEG 40 hydrogenated castor oil, butane, propane

Certus Recens Foam A 4802 Label and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product labelproduct label

Certus Recens Foam A 

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
BUTANEINACTIVE INGREDIENT6LV4FOR43R1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATEINACTIVE INGREDIENT4J55VM509S1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
PROPANEINACTIVE INGREDIENTT75W9911L61
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75990-77475990-774-25

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
ALCOHOL3K9958V90MACTIB
PROPANET75W9911L6IACT
BUTANE6LV4FOR43RIACT
WATER059QF0KO0RIACT
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE4J55VM509SIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
POLYSORBATE 6514BGY2Y3MJIACT
DIMETHICONE PEG-8 BENZOATE18KOO18SJPIACT
MEADOWFOAMAMIDOPROPYL BETAINEHNV0L650LGIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
STEARETH-20L0Q8IK9E08IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii candidate
13 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / RECTAL12 mgExact identifier — unii candidate
3 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii candidate
13 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / RECTAL9 mgExact identifier — unii candidate
2 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / VAGINAL0.03 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii candidate
3 equally ranked IID candidates

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
c5874a08-0323-3113-e053-2995a90a187240528aa2-69de-421a-822e-1d63a124315c2021-06-24WarningsExact identifier
spl set id: 40528aa2-69de-421a-822e-1d63a124315c

Reported adverse events (FAERS/openFDA)#

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