ALCOHOL ISOPROPILICO- isopropyl alcohol liquid 
PENSEUR PRODUCTS GROUP LLC

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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Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

First aid to help prevent the risk of infection in minor cuts, scrapes, and burns.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product do not get into eyes. do not apply over large areas of the body. do not use longer than one week unless directed by a doctor.


Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

118 ml NDC: 79878-004-00

118 ML Label237 ml NDC: 79878-004-01

237 ML Label 2473 ml NDC: 79878-004-02

473 ML Label946 ml NDC: 79878-004-03

946 ML Label3785 ml NDC: 79878-004-04

3785 ML Label 2

ALCOHOL ISOPROPILICO 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79878-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79878-004-00118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
2NDC:79878-004-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
3NDC:79878-004-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
4NDC:79878-004-03946 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
5NDC:79878-004-043785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/24/2020
Labeler - PENSEUR PRODUCTS GROUP LLC (117584143)
Registrant - PENSEUR PRODUCTS GROUP LLC (117584143)
Establishment
NameAddressID/FEIBusiness Operations
PENSEUR PRODUCTS GROUP LLC117584143manufacture(79878-004)

Revised: 8/2020
Document Id: ad8aa494-8b66-df4f-e053-2995a90a3119
Set id: ad8aa494-8b74-df4f-e053-2995a90a3119
Version: 1
Effective Time: 20200823
 
PENSEUR PRODUCTS GROUP LLC