BY PURE HAND SANI- alcohol gel
Iron Lab, S.A. de C.V.

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.

----------

By P'ure Hand Sani

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:

Label

BY PURE HAND SANI
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74375-008
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74375-008-01	1000000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020	07/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/06/2020	07/30/2021

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

Revised: 8/2021

Document Id: c95e9e0b-ae65-8c8a-e053-2995a90aa6d0

Set id: 86a94c60-7f8b-44e9-aba8-bcb2295efdd3

Version: 3

Effective Time: 20210812

Iron Lab, S.A. de C.V.