PL-0591- flexi hand sanitizer gel
Broder Bros Co.,

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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Active Ingredient

Ethyl Alcohol (62%)

Drug Fact

Purpose

Antiseptic

Use

Drug Facts for hand-washing to decrease bacteria on skin

Warnings

For external use only.

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Warnings

Flammable. Keep away from heat and flame.

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Warnings

Do not use in the eyes. In case of contact, rinse eyes throughly with water.

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Warnings

Stop use & ask a doctor if irritation and redness develops and persists for more than 72 hours.

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Warnings

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

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Directions

Wet hands throughly with product, briskly rub together until dry.
Always supervise children in use of this product.

Other Information

Store at 68º to 77°F (20° to 25°C)
May discolor certain fabrics

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Inactive ingredients

Aloe Barbadensis oil, Fragrance, Propylene glycol, Tocopherol, Water(Aqua)

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Questions?

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

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Lot no:

Use by:

Made in China

Distributed by: Prime Resource Corp Bridgeport, CT 06610

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Hand Sanitizer

PDP Hand Sanitizer

Net wt. 1 FL OZ (29.5mL)

Hand Sanitizer

Hand Santizer

2 FL OZ (59 mL)

PDP

PL-0591
flexi hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71513-059
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71513-059-01	30 mL in 1 POUCH; Type 0: Not a Combination Product	06/20/2017	01/01/2020
2	NDC:71513-059-03	60 mL in 1 POUCH; Type 0: Not a Combination Product	06/20/2017	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/20/2017	01/01/2020

Labeler - Broder Bros Co., (107044246)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co., Ltd.		529892305	manufacture(71513-059)

Revised: 11/2022

Document Id: ee8c081d-b2df-42ec-e053-2995a90aa898

Set id: 51d7ea6d-a633-20f9-e054-00144ff8d46c

Version: 6

Effective Time: 20221128

Broder Bros Co.,