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PL-0591 by Broder Bros Co.,

Dosage form: gel
Ingredients: ALCOHOL 62mL in 62mL
Labeler: Broder Bros Co.,
NDC Code: 71513-414

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.

Active Ingredient

Ethyl Alcohol (62%)

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on skin

Warnings

Flammable. Keep away from heat and flame.

Warnings

For external use only.

Warnings

When using this product do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water.

Warnings

Stop use & ask a doctor if skin irritation develops.

Warnings

Keep out of reach of children if swallowed, get medical help or contact a Poinson Control Center right away.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6 use only under adult supervision.
  • Not recommended for infants.

Other Information
  • Do not store above 105 F (40.55 C)
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

Inactive ingredients

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Questions?

1-800-873-7746 M-F 8am-5pm EST

Lot no:

Use by:

Made in China

Distributed by: Prime Resource Corp Bridgeport, CT 06610

Hand Sanitizer

Hand Sanitizer

Net wt. 0.66 FL OZ (19.52 mL)

PL-0591 
flexi hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71513-414
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 62 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE 
CARBOXYPOLYMETHYLENE 
GLYCERIN 
TOCOPHEROL 
WATER 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:71513-414-0120 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/20/2017
Labeler - Broder Bros Co., (005381652)
Registrant - Broder Bros Co., (005381652)
Establishment
NameAddressID/FEIOperations
Prime Resources Corp099761066relabel(71513-414), repack(71513-414)
Establishment
NameAddressID/FEIOperations
Yuyao Jessie Commodity Co., Ltd.529892305manufacture(71513-414)

Revised: 12/2017
 
Broder Bros Co.,

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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