PL-0591- flexi hand sanitizer gel

PL-0591 by

Drug Labeling and Warnings

PL-0591 by is a Otc medication manufactured, distributed, or labeled by Broder Bros Co.,, Prime Resources Corp, Yuyao Jessie Commodity Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

OTHER SAFETY INFORMATION

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)

INGREDIENTS AND APPEARANCE

PL-0591 
flexi hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71513-414
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 62 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71513-414-01	20 mL in 1 POUCH; Type 0: Not a Combination Product	06/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/20/2017

Labeler - Broder Bros Co., (005381652)

Registrant - Broder Bros Co., (005381652)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Resources Corp		099761066	relabel(71513-414) , repack(71513-414)

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Commodity Co., Ltd.		529892305	manufacture(71513-414)