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Hand Gel Prolim Instant Hand Sanitizer

Dosage form: gel
Ingredients: Alcohol 0.7mg in 1mL
Labeler: Prolim Quimica Avancada Ltda.
NDC Code: 50414-100

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.

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses
  • Recommended for aseptic hand cleansing. This product does not replace the use of soap and water.
  • Recommended for repeated use.

Warnings

For external use only

When using this product
  • Keep out of eyes. In case of accidental contact, flush eyes thoroughly with water for 15 minutes.
  • Avoid contact with broken skin or you have allergies to any ingredients.

Stop use and consult a doctor if skin irritation occurs.

Keep out of reach of children
  • In case of accidental ingestion drink plenty of water and seek medical help or contact a Poison Controll Center immediately.
  • External use only.

FLAMMABLE: Keep out of heat.

Directions
  • Place a small amount of product in your hand.
  • Rub hands together briskly for at least 30 seconds until dry.
  • Children under 6 years of age should use under adult supervision.

Inactive Ingredients

Water, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol,  Carbomer, DDM Hydantoin, Aminomethyl Propanol, Fragrance.

Questions?

555-555-5555

Principal Display Panel

HAND GEL PROLIM
INSTANT HAND SANITIZER
Kills 99,99% of most commom germs
2.7 OZ FL (80ml)

HAND GEL PROLIM INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50414-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (Alcohol) Alcohol0.7 mg  in 1 mL
Packaging
#Item CodePackage Description
1NDC:50414-100-0160 mL in 1 BOTTLE, PLASTIC
2NDC:50414-100-0280 mL in 1 BOTTLE, PLASTIC
3NDC:50414-100-03100 mL in 1 BOTTLE, PLASTIC
4NDC:50414-100-04200 mL in 1 BOTTLE, PUMP
5NDC:50414-100-05500 mL in 1 BOTTLE, PUMP
6NDC:50414-100-061000 mL in 1 BOTTLE, PUMP
7NDC:50414-100-075000 mL in 1 BOTTLE, PLASTIC
8NDC:50414-100-081 BAG (BAG) in 1 BOX
8800 mL in 1 BAG
9NDC:50414-100-091 BAG (BAG) in 1 BOX
91200 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33303/10/2010
Labeler - Prolim Quimica Avancada Ltda. (907224518)
Establishment
NameAddressID/FEIOperations
Prolim Quimica Avancada Ltda.907224518manufacture

Revised: 02/2010
Document Id: ac63737f-53f9-4668-8921-78f25a44f20b
Set id: 2c0441c7-96e9-4b2b-b851-527badd7429a
Version: 1
Effective Time: 20100215
 
Prolim Quimica Avancada Ltda.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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