PREMIER PURE PROTECTION- ethyl alcohol gel 
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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Active ingredient

Ethyl Alcohol 72% v/v

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 thoroughly with water 

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.

Directions

Other information

Inactive ingredients

Water, Glycerin, Ethanolamine, Carbomer, Propylene Glycol, Fragrance, Citric Acid

Product Label

image description

PREMIER PURE PROTECTION 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73945-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73945-004-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
2NDC:73945-004-0288.72 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
3NDC:73945-004-03118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
4NDC:73945-004-04236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
5NDC:73945-004-05295.74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
6NDC:73945-004-06354.88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
7NDC:73945-004-07443.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
8NDC:73945-004-08946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
9NDC:73945-004-091890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
10NDC:73945-004-102000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
11NDC:73945-004-112800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
12NDC:73945-004-123780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A04/10/2020
Labeler - RPP PRODUCTS, INC. (623623852)
Establishment
NameAddressID/FEIBusiness Operations
RPP PRODUCTS, INC.623623852manufacture(73945-004)

Revised: 5/2020
Document Id: 8f25edb6-72e1-4884-9687-f1fc00f02667
Set id: 3c11775e-0032-45ef-982c-1d3b78b00f46
Version: 1
Effective Time: 20200505
 
RPP PRODUCTS, INC.