PLANET LUXE HAND SANITIZER LAVENDER, BERGAMOT AND GERANIUM- 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 Lavender, Bergamot & Geranium

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

Bergamot (Citrus Aurantium Bergamia) Essential Oil, Glycerol (Plant), Hydrogen Peroxide, Lavandula Angustifolia (Lavender) Oil. Pelargonium Graveolens (Geranium) Flower Oil, Water

Package Labeling

Bottle 2

PLANET LUXE HAND SANITIZER LAVENDER, BERGAMOT AND GERANIUM 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81109-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
WATER (UNII: 059QF0KO0R)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81109-001-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/24/202012/30/2023
Labeler - PLANET LUXE OPERATIONS PTY LTD (746777443)
Establishment
NameAddressID/FEIBusiness Operations
PLANET LUXE OPERATIONS PTY LTD746777443manufacture(81109-001)

Revised: 10/2022
Document Id: ebceaae0-31a2-68ca-e053-2a95a90a837b
Set id: b5565e14-d0e7-0aaa-e053-2a95a90a5f8d
Version: 2
Effective Time: 20221024
 
PLANET LUXE OPERATIONS PTY LTD