SEA BAND MOTION-LESS- lavandula angustifolia oil, lavandula hybrida oil, mentha piperita (pepprermint) oil, cananga odorata flower oil, boswellia carterii oil, anthemis nobilis flower oil, commiphora myrrha oil liquid
Denison Pharmaceuticals, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Sea Band Motion-Less

Directions for use:

Using the roll-on applicator, rub a small amount of Motion-Less on to the side of your head behind each ear lobe. Feel the effects of Motion-Less within minutes. Reapply as required through the day. 40 applications

Warning: For external use only

Active ingredients

Lavandula Angustifolia (lavender) Oil, Lavandula Hydrida Oil, Mentha Piperita (peppermint) Oil, Cananga Odorata Flower Oil, Boswellia Carterii Oil, Anthemis Nobilis Flower Oil, Commiphora Myrrha Oil

Inactive ingredients

Water

Purpose

Calm and tranquility

Keep Out of Reach of Children

Recommneded for ages 5 and up. Avoid contact with eyes. Consult a physician if irritation occurs or if symptoms worsen or persist for more than a few days. If pregnant or nursing, consult a healthcare professional prior to use.

Store in a cold, dark place.

The oils are absorbed into the ski creating a sense of calm and tranquility, but will not leave you drowsy.

label

SEA BAND MOTION-LESS
lavandula angustifolia oil, lavandula hybrida oil, mentha piperita (pepprermint) oil, cananga odorata flower oil, boswellia carterii oil, anthemis nobilis flower oil, commiphora myrrha oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0295-8465
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8)	LAVENDER OIL	65 mg in 100 mL
MYRRH OIL (UNII: H74221J5J4) (MYRRH OIL - UNII:H74221J5J4)	MYRRH OIL	0.1 mg in 100 mL
FRANKINCENSE OIL (UNII: 67ZYA5T02K) (FRANKINCENSE OIL - UNII:67ZYA5T02K)	FRANKINCENSE OIL	0.1 mg in 100 mL
LAVANDIN OIL (UNII: 9RES347CKG) (LAVANDIN OIL - UNII:9RES347CKG)	LAVANDIN OIL	20 mg in 100 mL
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) (CHAMAEMELUM NOBILE FLOWER OIL - UNII:UB27587839)	CHAMAEMELUM NOBILE FLOWER OIL	0.1 mg in 100 mL
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	14.5 mg in 100 mL
CANANGA OIL (UNII: 8YOY78GNNX) (CANANGA OIL - UNII:8YOY78GNNX)	CANANGA OIL	0.2 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0295-8465-20	1 in 1 BOTTLE, WITH APPLICATOR	03/17/2020
1		5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/17/2020	05/13/2022

Labeler - Denison Pharmaceuticals, LLC (001207208)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-8465)

Revised: 5/2022

Document Id: dee74375-d87a-3ef7-e053-2995a90a5c65

Set id: a110f424-e64f-b729-e053-2995a90a9fb8

Version: 2

Effective Time: 20220513

Denison Pharmaceuticals, LLC