Natures Willow Bug Bite Patch

Natures Willow Bug Bite Patch by

Drug Labeling and Warnings

Natures Willow Bug Bite Patch by is a Homeopathic medication manufactured, distributed, or labeled by EUROSIREL SPA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURES WILLOW BUG BITE PATCH- calendula, salix alba patch 
EUROSIREL SPA

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.

----------

Natures Willow Bug Bite Patch

Active Ingredients

Calendula Officinalis Flower Extract 0.002 mg

Salix Alba (Willow) Bark Extract 0.004 mg

Purpose

Purpose*

Calendula Officinalis Flower Extract (0.002 mg)	...Reduces scarring, speeds healing
Salix Alba (Willow) Bark Extract (0.004 mg)	...Topical analgesic

Uses

Uses*

For the temporary relief of symptoms associated with insect bites.

Warnings

For external use only.

Avoid contact with eyes, mucous membranes, damaged skin or wounds.

Do not use if you are allergic to any ingredients in this product or by persons with known sensitivity to aspirin.

Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

If pregnant or breastfeeding, ask a healthcare professional before use.

Discontinue treatment in case of skin irritation, redness or rash occurs.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children over 12 years of age:

1. Clean and dry the affected area.

2. Peel of a patch from the the transparent backing.

3. Apply carefully on the affected area. To prevent touching the patch with your fingers, use the side tab.

4. Keep the patch on until the nuisance is gone. Do not exceed 8 hours of application.

Children under 12 years of age: consult a physician.

Other Information

Damaged packaging could compromise the operation and safety of the product.

• Do not use if packaging is broken or punctured.
• Disposable Single Use.
• Store in cool, dry place.

Inactive Ingredients

Acrylates Copolymer, Eucalyptus Globulus Leaf Oil, Glycine Soja Oil, Helichrysum Italicum Flower Extract, Lavandula Angustifolia Oil, Limonene, Linalool, Linseed Acid, Mentha Piperita (Peppermint) Oil, Menthol, Oleyl Alcohol, Pelargonium Graveolens Oil, Propylene Glycol, Tocopheryl Acetate, Vitis Vinifera Oil, Zanthoxylum Bungeanum Fruit Extract

Questions or comments?

Questions or comments? 1-888-609-4556

SPL Unclassified Section

*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.

Package Label

NATURES WILLOW BUG BITE PATCH 
calendula, salix alba patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71235-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	0.002 mg
SALIX ALBA BARK (UNII: 205MXS71H7) (SALIX ALBA BARK - UNII:205MXS71H7)	SALIX ALBA BARK	0.004 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
GRAPE SEED OIL (UNII: 930MLC8XGG)
MENTHOL (UNII: L7T10EIP3A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
SOYBEAN OIL (UNII: 241ATL177A)
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
PEPPERMINT OIL (UNII: AV092KU4JH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LINOLENIC ACID (UNII: 0RBV727H71)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71235-013-01	4 in 1 BOX	12/08/2021
1		10 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/08/2021

Labeler - EUROSIREL SPA (655512069)

Registrant - EUROSIREL SPA (655512069)

Revised: 12/2021

Document Id: cbf6e4c3-5a9d-c2ee-e053-2a95a90a8b85

34390-5

Set id: cbf6e4b3-6214-9660-e053-2a95a90a917f

Version: 1

Effective Time: 20211208