PREMIER PURE PROTECTION- 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

Use

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.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 PREMIER PURE.

Other information

Store below 110º F (43º C).
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.

Inactive ingredients

Water, Acrylates Copolymer, Glycerin, Hydrolyzed Jojoba Esters, Aminomethyl Propanol, Fragrance

Product Label

image description

PREMIER PURE PROTECTION
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73945-005
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73945-005-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
2	NDC:73945-005-02	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
3	NDC:73945-005-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
4	NDC:73945-005-04	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
5	NDC:73945-005-05	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020
6	NDC:73945-005-06	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/08/2020

Labeler - RPP Products, Inc. (623623852)