PROANDRE- alcohol denat aerosol, foam

Proandre by

Drug Labeling and Warnings

Proandre by is a Otc medication manufactured, distributed, or labeled by Proandre SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient Purpose

Alcohol Denat 68%............ Antibacterial

Uses

Uses

* Hand Sanitizer to help reduce bacteria that potentially may cause disease

Warnings

For external use only

Flammable. Keep away from fire or flame

When using this product

* Avoid contact with face, eyes and broken skin.

If eye contact occurs, flush thoroughly with water

and seek medical advice.

Stop use and ask a doctor if

Stop use and ask a doctor if

* Irritation and redness develops

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Directions

Directions

* Pump liquid into dry hands, wet thoroughly and rub

into skin until dry.

* Children under 6 years of age should be supervised by an

adult when using this product.

Inactive Ingredients

Water, Cocamidopropyl betaine

Questions?

Questions?

1(305) 961 1156

Uses

Hand sanitizer to help reduce bacteria on hands. Avoid

contact with broken skin

Antibacterial Hand Sanitizer Foam

Antibacterial Hand Sanitizer Foam

Fragrance Free

INGREDIENTS AND APPEARANCE

PROANDRE 
alcohol denat aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70028-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	10 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	50 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70028-003-11	800 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/20/2017

Labeler - Proandre SL (463207675)

Registrant - Proandre SL (463207675)

Establishment
Name	Address	ID/FEI	Business Operations
Proandre SL		463207675	manufacture(70028-003)