ANTISEPTIC HAND SANITIZER- isopropyl alcohol gel 
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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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Antiseptic Hand Sanitizer

Drug Facts

Active ingredient

Isopropyl alcohol 70%

Purpose

Antiseptic

Uses

Warnings

For external use only
Flammable, keep away from fire or flame.

Do not use

in the eyes

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

carbomer, imidazolidinyl urea, PEG-12 dimethicone, propylene chlorhexidine gluconate, triethanolamine, water

Questions or Comments?

+1 (888) 408-1694

Package Labeling:

Outer PackageInner PackageBox

ANTISEPTIC HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74785-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
IMIDUREA (UNII: M629807ATL)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74785-000-00250 in 1 BOX05/01/2020
11.5 mL in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - V-Shapes Srl (438846579)

Revised: 5/2020
Document Id: a4d7bc53-cffb-7f55-e053-2995a90a2d1c
Set id: a4d7b414-ef71-b2e7-e053-2a95a90ada12
Version: 1
Effective Time: 20200504
 
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