PREMIER PURE PROTECTION- ethyl alcohol gel

PREMIER PURE Protection by

Drug Labeling and Warnings

PREMIER PURE Protection by is a Otc medication manufactured, distributed, or labeled by RPP PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• children under 6 years of age should be supervised when using this PREMIER PURE

Other information

• Store below 1100 F (430C)
•  May discolor certain fabrics or surfaces 
• This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm

KEEP OUT OF REACH OF CHILDREN

Inactive ingredients

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

Product Label

INGREDIENTS AND APPEARANCE

PREMIER PURE PROTECTION 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73945-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73945-004-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
2	NDC: 73945-004-02	88.72 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
3	NDC: 73945-004-03	118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
4	NDC: 73945-004-04	236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
5	NDC: 73945-004-05	295.74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
6	NDC: 73945-004-06	354.88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
7	NDC: 73945-004-07	443.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
8	NDC: 73945-004-08	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
9	NDC: 73945-004-09	1890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
10	NDC: 73945-004-10	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
11	NDC: 73945-004-11	2800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020
12	NDC: 73945-004-12	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	04/10/2020

Labeler - RPP PRODUCTS, INC. (623623852)

Establishment
Name	Address	ID/FEI	Business Operations
RPP PRODUCTS, INC.		623623852	manufacture(73945-004)