Lavender Scented Hand Sanitizer 01: Package Insert and Label Information

LAVENDER SCENTED HAND SANITIZER 01- alcohol gel
BBC GROUP LIMITED

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 ………….purpose

alcohol Denate: 70%(v/v)….. Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only-hands

keep out of eyes- avoid contact with broken skin.

Keep away from fire.

Stop use and ask a dosctor if irritation or radness develops

Do not inhale or ingest. If swallowed, get medical help or contact a poison control right away.

Direction

Rub a dime sized drop into hands.

For children under 8 use under adult supervision

Inactive ingredients

INACTIVE INGREDIENTS: WATER(AQUA/EAU), PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE( PARFUM), ACRYLATES/ c10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE.
MAY CONTAIN: FD&C RED 40, D&C RED 33, FD&C BLUE 1, FD&C YELLOW 5.

Questions?

1-212-779-0544 weekdays

LAVENDER SCENTED HAND SANITIZER 01 alochol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76383-082 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER 36.2397 g in 100 mL FD&C RED NO. 40 0.0003 g in 100 mL TROLAMINE 0.16 g in 100 mL LAVENDER OIL 0.2 g in 100 mL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 0.2 mL in 100 mL POLYOXYL 40 HYDROGENATED CASTOR OIL 0.2 mL in 100 mL

Product Characteristics Color red Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76383-082-01 59 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 06/19/2020

Labeler — BBC GROUP LIMITED (421270060)

Registrant — Townley Inc. (016956158)

Establishment
Name	Address	ID/FEI	Operations
Townley Inc.		016956158	label (76383-082)

Establishment
Name	Address	ID/FEI	Operations
BBC GROUP LIMITED		421270060	manufacture (76383-082)

Revised: 06/2020 BBC GROUP LIMITED