Gel Antiseptic Handwash: Package Insert and Label Information

GEL ANTISEPTIC HANDWASH- alcohol liquid
Shop Bee’s Wax LLC

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 60%……….Antiseptic

purpose

Antiseptic

Uses

• Handwash to help decrease bacterial on the skin.
• Recommended for repeated use.

Warnings

• Flammable. Keep away from fire or flame.
• For external use only.

do not use

• In the eyes

When Using

• Do not use in or near the eyes.
• If contact occurs, flush eyes with water for 15 minutes. Consult physician if irritation persists.
• If swallowed, seek medical assistance or consult a poison control center immediately.

Stop Use

• Stop use and ask a doctor if: Irritation develops. If condition persists for more than 72 hours consult a doctor.
• Keep out of reach of children.

• Keep out of reach of children.

Directions for Use

• Place a palmful ( 5 grams) of product in one hand,.
• Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).
• Place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds).
• Will air dry in 15 seconds.

• Store below 95 ^o F.
• Close spout to avoid evaporation.

Water, triethanolamine, fragrance, acrylic polymer

GEL ANTISEPTIC HANDWASH gel antiseptic handwash liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81628-693 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 67 mL in 100 mL

Inactive Ingredients Ingredient Name Strength CARBOMER 940 TROLAMINE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:81628-693-01 118 mL in 1 BOTTLE, PLASTIC None 2 NDC:81628-693-03 3785 mL in 1 BOTTLE, PLASTIC None 3 NDC:81628-693-02 236 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/16/2012

Labeler — Shop Bee’s Wax LLC (116958891)

Establishment
Name	Address	ID/FEI	Operations
QuestSpecialty Corporation		103840377	manufacture (81628-693)

Revised: 03/2021 Shop Bee’s Wax LLC