PL-1808: Package Insert and Label Information

PL-1808- alcohol gel
PL-1807- alcohol 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.

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. If contact occurs, rinse eyes thoroughly with water.

Warnings

Stop use & ask a doctor if skin irritation develops and continues for more than 72 horus.

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
• Always supervise children in use of this product

Other Information

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

Other information

• 

  (click image for full-size original)

PL-1808 back label

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)

Hand Sanitizer

2.19 oz. (64.76 mL)

PL-1808 tee sanitizer spray . gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71513-101 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 62 mL

Inactive Ingredients Ingredient Name Strength TROLAMINE CARBOMER 940 GLYCERIN WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71513-101-01 65 mL in 1 BOTTLE None

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

PL-1807 tee sanitizer spray . gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71513-100 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 62 mL

Inactive Ingredients Ingredient Name Strength TROLAMINE CARBOMER 940 GLYCERIN WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71513-100-01 20 mL in 1 BOTTLE None

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	Operations
Prime Resources Corp		099761066	relabel (71513-100), repack (71513-100), relabel (71513-101), repack (71513-101)

Establishment
Name	Address	ID/FEI	Operations
Yuyao Jessie Commodity Co., Ltd.		529892305	manufacture (71513-100), manufacture (71513-101)

Revised: 09/2019 Broder Bros Co.,