Hand Sanitizer BY Pure by Iron Lab, S.A. de C.V. Hand Sanitizer BY Pure

Hand Sanitizer BY Pure by

Drug Labeling and Warnings

Hand Sanitizer BY Pure 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]

HAND SANITIZER BY PURE- 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.

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Hand Sanitizer BY Pure

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 or 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

HAND SANITIZER BY PURE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74375-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74375-006-2020000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/202007/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/25/202007/30/2021
Labeler - Iron Lab, S.A. de C.V. (951575800)

Revised: 8/2021
 

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