BY PURE HAND SANITIZER- alcohol gel

By Pure Hand Sanitizer by

Drug Labeling and Warnings

By Pure Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Iron Lab, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Ethyl alcohol 70%

Purpose

Antiseptic Alcohol

Use

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

For external use only: hands. Flammable, Keep away from fire of flame.

When using this product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if

Irritation or redness develops. Condition persist for more than 72 hours.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions 

Thoroughly cover your hands with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Other information

Store below 105°F. May discolor some fabrics. Harmful to wood finishes and plastics.

Inactive ingredients

Water, propylene glycol, carbomer, triethanolamine.

Package Labeling: 125ml

Package Labeling: 200ml

Package Labeling: 1.8L

Package Labeling: 5L

INGREDIENTS AND APPEARANCE

BY PURE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74375-005
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74375-005-01	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
2	NDC: 74375-005-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
3	NDC: 74375-005-03	1800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
4	NDC: 74375-005-04	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/24/2020

Labeler - Iron Lab, S.A. de C.V. (951575800)