OTC Medication Information: Antibacterial Hand Sanitizer

ANTIBACTERIAL HAND SANITIZER- alcohol gel
Tiege Hanley

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.

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

• for hand washing to decrease bacteria on the skin
• recommended for repeated use

Warnings

For external use only.

Flammable. Keep away from fire or flame.

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

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

If swallowed get medical help or contact poison control center right away.

Keep Out of reach of children.

Directions

• wet hands thoroughly with product
• briskly rub hands together until dry
• Supervise children in the use of this product.

Other Information

• store at 20-25° C (68 to 77°F)
• may discolor certain fabrics

Inactive Ingredients

Water, Propylene Glycol, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Peg-60, Almond Glycerides, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Triisopropanolamine, Fragrance

Distributed by Tiege Hanley LLC
Chicago, IL 60612

PRINCIPAL DISPLAY PANEL — 59 mL Bottle Label

TIÉGE
HANLEY

Uncomplicated
Skin Care for Men^®

HAND SANITIZER

Kills 99.99% of
All Germs

2 fl oz (59 mL)

ANTIBACTERIAL HAND SANITIZER alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71714-059 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (alcohol) alcohol 62 mL in 100 mL

Inactive Ingredients Ingredient Name Strength Propylene Glycol water PEG-60 ALMOND GLYCERIDES aloe vera leaf .Alpha.-Tocopherol Acetate triisopropanolamine CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71714-059-02 59 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 03/31/2020

Labeler — Tiege Hanley (080305325)

Registrant — BMC 1092, Inc. dba Solo Laboratories, Inc. (078831987)

Establishment
Name	Address	ID/FEI	Operations
BMC 1092, Inc. dba Solo Laboratories, Inc.		078831987	MANUFACTURE (71714-059), LABEL (71714-059), PACK (71714-059)

Revised: 03/2020 Tiege Hanley