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NDC 75990-0968-17 Recens Foam 0.7 mL/mL Details

Recens Foam 0.7 mL/mL

Recens Foam is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Certus Medical, Inc.. The primary component is ALCOHOL.

Product Information

NDC	75990-0968
Product ID	75990-968_ea3864c4-d9b7-364d-e053-2995a90aba1a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Recens Foam
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.7
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	Certus Medical, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 75990-0968-17 (75990096817)

Pricing Information	N/A
NDC Package Code	75990-968-17
Billing NDC	75990096817
Package	532 mL in 1 BOTTLE, PLASTIC (75990-968-17)
Marketing Start Date	2022-10-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ea384dfc-c894-3124-e053-2a95a90a81c2 Details

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

INGREDIENTS AND APPEARANCE

RECENS FOAM

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75990-968
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75990-968-07	700 mL in 1 BAG; Type 0: Not a Combination Product	10/04/2022
2	NDC:75990-968-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	10/04/2022
3	NDC:75990-968-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/04/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/04/2022

Labeler - Certus Medical, Inc. (118806847)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(75990-968)

Revised: 10/2022

Document Id: ea3864c4-d9b7-364d-e053-2995a90aba1a

Set id: ea384dfc-c894-3124-e053-2a95a90a81c2

Version: 1

Effective Time: 20221004