SANI CLEAN PLUS- isopropyl alcohol gel 
First Galaxy Enterprises, 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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Sani Clean Plus 70% IPA lemon scented acrylates AMAZON

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

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, lemon fragrance, PEG-6 AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, purified water USP

Package Label - Principal Display Panel

236 ml NDC 90082-382-08.jpg

SANI CLEAN PLUS 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90082-382
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
LEMON (UNII: 24RS0A988O)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90082-382-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/10/2020
2NDC:90082-382-16437 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/10/2020
Labeler - First Galaxy Enterprises, Inc. (114966288)
Establishment
NameAddressID/FEIBusiness Operations
HPPE LLC078769356manufacture(90082-382)

Revised: 10/2021
Document Id: cef57bf1-4994-897e-e053-2a95a90a307d
Set id: ac8aeb40-a0a6-10bd-e053-2995a90a791a
Version: 3
Effective Time: 20211022
 
First Galaxy Enterprises, Inc.