ITCH RELIEF- apis mellifera, lachesis muta venom, ledum palustre twig and urtica urens liquid

Itch Relief by

Drug Labeling and Warnings

Itch Relief 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

Apis mellifica 12X

Purpose

stinging, pain, redness, burning

Active Ingredient

Lachesis mutus 12X

Purpose

burning, skin discoloration

Active Ingredient

Ledum palustre 6X

Purpose

itching, skin irritation

Active Ingredient

Urtica urens 8X

Purpose

itching, burning, skin irritation and rashes

Uses:

According to homeopathic principles, the active ingredients in this product temporarily relieve pain and itching associated with insect bites & stings and minor skin irritations due to poison ivy, oak & sumac.

Warnings:

• For external use only.
  
• 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.

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: Moisten the affected area with roller ball at short intervals several times a day until the symptoms clearly diminish. Continue to apply 3-6 times daily until the affected area is completely healed.

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

Alcohol, 40%, Vegetable glycerin

Questions?

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

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-401-42
Similasan®
Itch Relief  
ROLL-ON
7.5 mL/0.25 fl oz

INGREDIENTS AND APPEARANCE

ITCH RELIEF 
apis mellifera, lachesis muta venom, ledum palustre twig and urtica urens liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X]  in 7.5 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X]  in 7.5 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]  in 7.5 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	8 [hp_X]  in 7.5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-401-42	1 in 1 BOX
1		7.5 mL in 1 BOTTLE, WITH APPLICATOR; 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(59262-401) , MANUFACTURE(59262-401) , PACK(59262-401)