PLANET LUXE HAND SANITIZER CEDARWOOD, YLANG YLANG AND CLARY SAGE- alcohol spray
PLANET LUXE OPERATIONS PTY LTD

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.

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Planet Luxe Hand Sanitizer Cedarwood, Ylang Ylang & Clary Sage

Drug Facts

Active ingredients

Ethyl Alcohol (80%)

Antiseptic

Uses

To help reduce bacteria on the skin

Warnings

Flammable- keep away from fire or flame.

For external use only.

Stop use and ask a doctor if

irritation or redness develops.

When using this product,

avoid Contact With eyes. In case of eye Contact, flush eyes With water.

Keep out of reach of children.

If swallowed, get medical help or Contact Poison Control Center right away.

Directions

Spray onto the palm of one hand and rub hands together, distribute Over all Surfaces of hands and fingers until dry.
Not recommended for infants. Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Cananga Odorata (Ylang Ylang) Fower Oil, Cedrus Atlantica (Cedarwood) Bark Oil, Glycerol (Plant), Hydrogen Peroxide, Salvia Sclarea (Clary) Oil, Water

Package Labeling

Bottle

PLANET LUXE HAND SANITIZER CEDARWOOD, YLANG YLANG AND CLARY SAGE
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81109-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CANANGA OIL (UNII: 8YOY78GNNX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81109-000-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/24/2020	12/30/2023

Labeler - PLANET LUXE OPERATIONS PTY LTD (746777443)

Revised: 10/2022

Document Id: ebce8707-c9d6-79cd-e053-2995a90a08e0

Set id: b55646ab-d4d2-0f52-e053-2a95a90acd5b

Version: 2

Effective Time: 20221024

PLANET LUXE OPERATIONS PTY LTD