PREMIER INSTANT- alcohol 80% liquid 
RPP PRODUCTS, 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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PREMIER INSTANT HAND SANITIZER

Active ingredient

Ethyl alcohol 80%, USP

Purpose

Antimicrobial

Uses

hand sanitizer to help reduce bacteria on the skin 

Warnings

Flammable, keep away from fire or flame

For external use only

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask doctor if

irritation or rash appears and lasts

Keep out of reach of children.

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

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Other information

Inactive ingredient

Water(DI), Glycerin, Text-butyl Alcohol, Denatonium Bezoate

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PREMIER INSTANT 
alcohol 80% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73945-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73945-001-0159.14 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
2NDC:73945-001-02236.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
3NDC:73945-001-03443.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
4NDC:73945-001-04946.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
5NDC:73945-001-052011 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A03/23/2020
Labeler - RPP PRODUCTS, INC. (623623852)
Establishment
NameAddressID/FEIBusiness Operations
RPP PRODUCTS, INC.623623852manufacture(73945-001)

Revised: 3/2020
Document Id: 495e606d-9bea-4b1c-bb2c-d14ec4527f0a
Set id: 902a783c-f6fc-4461-9a86-ee2d97cb5926
Version: 1
Effective Time: 20200325
 
RPP PRODUCTS, INC.