SKIN IRRITATIONS AND ITCH RELIEF- arsenicum album, agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum lodatum, bovista, causticum, dolichos pruriens, fagopyrum esculentum, graphites, kali muriaticum, muriaticum acidum, oleander, petroleum, pix liquida, radium bromatum, rhus toxicodendron, selenium metallicum, sulphur, urtica urens liquid

Skin Irritations and Itch Relief by

Drug Labeling and Warnings

Skin Irritations and Itch Relief by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Arsenicum album, ​Agaricus muscarius, Alumina, Anagallis arvensis, Antimonium tartaricum, Apis mellifica, Arsenicum lodatum, Bovista, Causticum, Dolichos pruriens, Fagopyrum esculentum, Graphites, Kali muriaticum, Muriaticum acidum, Oleander, Petroleum, Pix liquida, Radium bromatum (12X, 30X,100X,1M,LM1,LM2, LM3), Rhus toxicodendron, Selenium metallicum, Sulphur, Urtica urens. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies, unless otherwise noted.

INDICATIONS & USAGE

Uses for temporary relief of irritations and itching from: rashes, hives, and red, burning, sensitive, dry, rough, scaly or chapped skin.

INACTIVE INGREDIENT

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS

Warnings

• Stop use and ask your doctor if symptoms persist or worsen.
• If pregnant or breast-feeding, take only on advice of a healthcare professional.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• Initially, depress pump until primed.
• Spray one dose directly into mouth.
• Adults 12 and up: 3 sprays 3 times per day
• Children 2-12: 2 sprays 3 times per day
• Children 2mo-2yr: 1 spray 3 times per day

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

PURPOSE

Uses ​for temporary relief of irritations and itching from: rashes, hives, and red, burning, sensitive, dry, rough, scaly or chapped skin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN IRRITATIONS AND ITCH RELIEF 
arsenicum album, agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum lodatum, bovista, causticum, dolichos pruriens, fagopyrum esculentum, graphites, kali muriaticum, muriaticum acidum, oleander, petroleum, pix liquida, radium bromatum, rhus toxicodendron, selenium metallicum, sulphur, urtica urens liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-0168
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]  in 59 mL
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA FRUITING BODY	10 [hp_X]  in 59 mL
ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933)	ALUMINUM OXIDE	10 [hp_X]  in 59 mL
ANAGALLIS ARVENSIS (UNII: 46883LR90E) (ANAGALLIS ARVENSIS - UNII:46883LR90E)	ANAGALLIS ARVENSIS	10 [hp_X]  in 59 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	10 [hp_X]  in 59 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	10 [hp_X]  in 59 mL
ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIIODIDE	10 [hp_X]  in 59 mL
LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F)	LYCOPERDON UTRIFORME FRUITING BODY	10 [hp_X]  in 59 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	10 [hp_X]  in 59 mL
MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C)	MUCUNA PRURIENS FRUIT TRICHOME	10 [hp_X]  in 59 mL
FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N)	FAGOPYRUM ESCULENTUM	10 [hp_X]  in 59 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	10 [hp_X]  in 59 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	10 [hp_X]  in 59 mL
HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB)	HYDROCHLORIC ACID	10 [hp_X]  in 59 mL
NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) (NERIUM OLEANDER LEAF - UNII:7KV510R6H6)	NERIUM OLEANDER LEAF	10 [hp_X]  in 59 mL
KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E)	KEROSENE	10 [hp_X]  in 59 mL
PINE TAR (UNII: YFH4WC535J) (PINE TAR - UNII:YFH4WC535J)	PINE TAR	10 [hp_X]  in 59 mL
RADIUM BROMIDE (UNII: R74O7T8569) (RADIUM CATION - UNII:05456MVL7T)	RADIUM BROMIDE	12 [hp_X]  in 59 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	10 [hp_X]  in 59 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	10 [hp_X]  in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 [hp_X]  in 59 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-0168-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/06/2012

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-0168)