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NDC 75990-0783-22 Recens Hand Sanitizer Wipes 620 mg/g Details

Recens Hand Sanitizer Wipes 620 mg/g

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

Product Information

NDC	75990-0783
Product ID	75990-783_d2d39adf-db42-4f23-961f-e4c858df34b3
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 Hand Sanitizer Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	620
Active Ingredient Units	mg/g
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 75990-0783-22 (75990078322)

Pricing Information	N/A
NDC Package Code	75990-783-22
Billing NDC	75990078322
Package	295 g in 1 CANISTER (75990-783-22)
Marketing Start Date	2011-09-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 073cd741-b4a4-4ef2-a345-dde8939ae7a7 Details

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

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

wet hands thoroughly with product and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, propylene glycol

Recens Hand Sanitizer Wipes 7830 Drug Facts and Label

Recens Hand Sanitizer Wipes 7830 Label

INGREDIENTS AND APPEARANCE

RECENS HAND SANITIZER WIPES

alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75990-783
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75990-783-22	295 g in 1 CANISTER; Type 0: Not a Combination Product	09/23/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/23/2011

Labeler - Certus Medical, Inc. (966433653)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(75990-783)

Revised: 11/2018

Document Id: d2d39adf-db42-4f23-961f-e4c858df34b3

Set id: 073cd741-b4a4-4ef2-a345-dde8939ae7a7

Version: 2

Effective Time: 20181129