CERTUS RECENS A- alcohol aerosol, foam

Certus Recens A by

Drug Labeling and Warnings

Certus Recens A by is a Otc medication manufactured, distributed, or labeled by Certus Medical, Inc., ABC Compounding Co., Inc., ABC Compounding Company of Texas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Box OTC-Active Ingredients Section

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications and Usage Section

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

Drug Facts Box OTC-Warnings Section

Flammable, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box 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

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

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

Certus Recens Foam A 

INGREDIENTS AND APPEARANCE

CERTUS RECENS A 
alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75990-774
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPANE (UNII: T75W9911L6)
BUTANE (UNII: 6LV4FOR43R)
WATER (UNII: 059QF0KO0R)
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYSORBATE 65 (UNII: 14BGY2Y3MJ)
DIMETHICONE PEG-8 BENZOATE (UNII: 18KOO18SJP)
MEADOWFOAMAMIDOPROPYL BETAINE (UNII: HNV0L650LG)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
STEARETH-20 (UNII: L0Q8IK9E08)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75990-774-25	199 g in 1 CAN; Type 0: Not a Combination Product	04/25/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/25/2011

Labeler - Certus Medical, Inc. (966433653)

Registrant - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Company of Texas, Inc.		026219253	manufacture(75990-774)