PUREGEL ADVANCED SURFACE DISINFECTANT- ethyl alcohol liquid

PureGel Advanced Surface Disinfectant by

Drug Labeling and Warnings

PureGel Advanced Surface Disinfectant by is a Otc medication manufactured, distributed, or labeled by Alchemy Nutra LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 80% v/v.

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin that could cause disease.
• recommended for repeated use

Warnings

For external use only: hands

Flammable, keep away from fire or flame

When using this product  keep out of eyes. In case of contact with eyes, flush throughlywith water. 

Avoid contact with broken skin.

Do not inhale or ingest.

Stop using and ask a doctor if  irritation and redness develops 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 For children under 6, use only under adult supervision Not recommended for infants

Other Information:  Do not store above 105°F. may discolor some fabrics.

Inactive ingredients

Purified water, glycerin, Hydrogen Peroxide, Vitamin E

Product label

INGREDIENTS AND APPEARANCE

PUREGEL ADVANCED SURFACE DISINFECTANT 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75494-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75494-004-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2020
2	NDC: 75494-004-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2020
3	NDC: 75494-004-03	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2020
4	NDC: 75494-004-04	1040990 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/13/2020

Labeler - Alchemy Nutra LLC (117481753)

Establishment
Name	Address	ID/FEI	Business Operations
Alchemy Nutra LLC		117481753	manufacture(75494-004)