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NDC 63830-0855-14 Prevent 0.62 mL/mL Details

Prevent 0.62 mL/mL

Prevent is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Pro Chem, Incorporated. The primary component is ALCOHOL.

Product Information

NDC	63830-0855
Product ID	63830-855_04592bcf-e266-4259-b798-ab97c0228414
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	Prevent
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.62
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	Pro Chem, Incorporated
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 63830-0855-14 (63830085514)

Pricing Information	N/A
NDC Package Code	63830-855-14
Billing NDC	63830085514
Package	3785 mL in 1 BOTTLE, PLASTIC (63830-855-14)
Marketing Start Date	2019-07-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 11b58699-8a04-43b7-8f69-3bf8b1d7addb 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

press pump twice to deliver two squirts (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 Ingredient Section

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

Prevent 6585

Suds Prevent 6585 Label

INGREDIENTS AND APPEARANCE

PREVENT

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63830-855
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 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:63830-855-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2019
2	NDC:63830-855-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2019
3	NDC:63830-855-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/08/2019
4	NDC:63830-855-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2019
5	NDC:63830-855-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2019
6	NDC:63830-855-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/01/2009

Labeler - Pro Chem, Incorporated (061396065)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(63830-855)

Revised: 2/2020

Document Id: 04592bcf-e266-4259-b798-ab97c0228414

Set id: 11b58699-8a04-43b7-8f69-3bf8b1d7addb

Version: 4

Effective Time: 20200221