HAND GEL PROLIM INSTANT HAND SANITIZER- alcohol gel

Hand Gel Prolim Instant Hand Sanitizer by

Drug Labeling and Warnings

Hand Gel Prolim Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Prolim Quimica Avancada Ltda.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

SPL UNCLASSIFIED SECTION

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?

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Principal Display Panel

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

INGREDIENTS AND APPEARANCE

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	03/10/2010

Labeler - Prolim Quimica Avancada Ltda. (907224518)

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