BURN RECOVERY- calendula officinalis flowering top, lytta vesicatoria, echinacea, unspecified, urtica urens spray
Similasan Corporation

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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Burn Recovery

Drug Facts

Active Ingredient

Calendula officinalis 4X

Purpose

aids in skin recovery, soothes redness

Active Ingredient

Cantharis 6X

Purpose

burns/sunburns, itching

Active Ingredient

Echinacea 4X

Purpose

redness, burning pain

Active Ingredient

Urtica urens 4X

Purpose

stinging, itching, scalds, burns/sunburns

Uses:

According to homeopathic principles, the active ingredients in this product temporarily relieve pain, redness, and itching associated with sunburns or minor burns.

Warnings:

For external use only. Do not use on open wounds, on mucous membranes or on serious burns.
Do not use if you have a known case of hypersensitivity to Asteracea flowers.
Initial exacerbation of symptoms may occur.
Avoid contact with the eyes.
If conditions worsen or persist for more than 72 hours discontinue use and consult a physician.
Severe burns must immediately be treated by a physician.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions:

For adults and children age 2 and over: Spray on the affected area 3-4 times a day.

Can be used as a compress by saturating a clean cloth or gauze. Place on affected area and secure with a bandage. Re-moisten several times a day.

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

Alcohol, 25%

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-400-41
Similasan®
Burn
Recovery
COOLING SPRAY
90 mL/3.04 fl oz

PRINCIPAL DISPLAY PANEL
NDC 59262-400-41
Similasan®
Burn
Recovery
COOLING SPRAY
90 mL/3.04 fl oz

BURN RECOVERY
calendula officinalis flowering top, lytta vesicatoria, echinacea, unspecified, urtica urens spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59262-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	4 [hp_X] in 90 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	6 [hp_X] in 90 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	4 [hp_X] in 90 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	4 [hp_X] in 90 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59262-400-41	1 in 1 BOX	11/01/2014	05/01/2023
1		90 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/01/2014	05/01/2023

Labeler - Similasan Corporation (111566530)

Name	Address	ID/FEI	Business Operations
Establishment
Similasan AG		481545754	label(59262-400) , manufacture(59262-400) , pack(59262-400)

Revised: 5/2023

Document Id: beb65b40-4897-46f4-9bcb-8b2f0158fcf0

Set id: 2dfc01c1-4d57-4862-831e-eeef5d767499

Version: 3

Effective Time: 20230504

Similasan Corporation