RECENS FOAM- alcohol liquid 
Certus Medical, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Recens Foam 6968 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 70% v/v

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & 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

 apply to hands and rub lightly until dry without wiping or rinsing

Drug Facts Box OTC-Inactive Ingredient Section

water, PEG-10 acrylate, perfluorohexylethyl acrylate copolymer, propylene glycol

Recens Foam 6968

image descriptionRecens Foam 6968

RECENS FOAM 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-968
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75990-968-07700 mL in 1 BAG; Type 0: Not a Combination Product10/04/2022
2NDC:75990-968-121000 mL in 1 BAG; Type 0: Not a Combination Product10/04/2022
3NDC:75990-968-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/04/2022
Labeler - Certus Medical, Inc. (118806847)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(75990-968)

Revised: 10/2022
Document Id: ea3864c4-d9b7-364d-e053-2995a90aba1a
Set id: ea384dfc-c894-3124-e053-2a95a90a81c2
Version: 1
Effective Time: 20221004
 
Certus Medical, Inc.