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

76383-082-01
(click image for full-size original)

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

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