OTC Medication Information: Proandre

PROANDRE- alcohol aerosol, foam
Proandre SL

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.

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

Bottle
(click image for full-size original)
PROANDRE
alcohol denat aerosol, foam
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70028-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
COCAMIDOPROPYL BETAINE 10 mg in 1 mL
WATER 50 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70028-003-11 800 mL in 1 BOTTLE, DISPENSING None
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 Operations
Proandre SL 463207675 manufacture (70028-003)

Revised: 06/2017 Proandre SL

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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