HAND GEL PROLIM INSTANT HAND SANITIZER - alcohol gel
Prolim Quimica Avancada Ltda.

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

image of label - bottle

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50414-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	0.7 mg in 1 mL

#	Item Code	Package Description
Packaging
1	NDC:50414-100-01	60 mL in 1 BOTTLE, PLASTIC
2	NDC:50414-100-02	80 mL in 1 BOTTLE, PLASTIC
3	NDC:50414-100-03	100 mL in 1 BOTTLE, PLASTIC
4	NDC:50414-100-04	200 mL in 1 BOTTLE, PUMP
5	NDC:50414-100-05	500 mL in 1 BOTTLE, PUMP
6	NDC:50414-100-06	1000 mL in 1 BOTTLE, PUMP
7	NDC:50414-100-07	5000 mL in 1 BOTTLE, PLASTIC
8	NDC:50414-100-08	1 in 1 BOX
8		800 mL in 1 BAG
9	NDC:50414-100-09	1 in 1 BOX
9		1200 mL in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	03/10/2010

Labeler - Prolim Quimica Avancada Ltda. (907224518)

Name	Address	ID/FEI	Business Operations
Establishment
Prolim Quimica Avancada Ltda.		907224518	manufacture