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

Burn Recovery by

Drug Labeling and Warnings

Burn Recovery by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation, Similasan AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		11/01/2014

Labeler - Similasan Corporation (111566530)

Establishment
Name	Address	ID/FEI	Business Operations
Similasan AG		481545754	LABEL(59262-400) , MANUFACTURE(59262-400) , PACK(59262-400)