Label: SKIN IRRITATIONS AND ITCH RELIEF- agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum album, arsenicum iodatum, 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
- NDC Code(s): 57955-2817-2
- Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 12, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Directions
Initially, depress pump until
primed.Spray one dose directly into
mouth.Adults: 3 sprays 3 times per
day.Children ages 6-12: 2 sprays 3
times per day.Consult a physician for use in
children under 6 years of age.Use additionally as needed, up
to 6 times per day.Reference image:Skin Irritations.jpg
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OTHER SAFETY INFORMATION
Other information
Tamper resistant for your protection.
Use only if safety seal is intact.
Keep carton for complete drug facts and product information.
Questions? Call 866.298.2740
King Bio, Inc. 3 Westside Drive
Asheville, NC 2806 USA
FDA Reg. #1053442
For latest product information and instructions: www.DrKings.com
Reference image:Skin Irritations.jpg
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Inactive Ingredients
Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).
Reference image:Skin Irritations.jpg
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Active ingredients
Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies, unless otherwise noted.Agaricus muscarius, Alumina, Anagallis arvensis, Antimonium tartaricum, Apis mellifica, Arsenicum album, Arsenicum iodatum, Bovista,
Causticum, Dolichos pruriens, Fagopyrum esculentum, Graphites, Kali muriaticum, Muriaticum acidum, Oleander, Petroleum, Pix liquida,
Radium bromatum 12X, 30X, & LM1, Rhus toxicodendron, Selenium metallicum, Sulphur, Urtica urens.HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.
Reference image:Skin Irritations.jpg
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Uses
Uses for symptomatic relief of irritated skin, such as:
Itching
Rash
Hives
Redness
Burning
Sensitivity
Dryness
Scales
Dryness
Roughness
as per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.Reference image:Skin Irritations.jpg
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Warnings
Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.If pregnant or breast-feeding, ask a healthcare professional
before use.Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center immediately.
Reference image:Skin Irritations.jpg
- KEEP OUT OF REACH OF CHILDREN
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PURPOSE
Active ingredients Purpose †
Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies, unless otherwise noted.Agaricus muscarius ...................................................itching skin
Alumina .....................................................chapped, itching skin
Anagallis arvensis .........................................itching, tingling skin
Antimonium tartaricum .........................................itching pimples
Apis mellifica ..............................................stinging pains on skin
Arsenicum album.........................................dry, rough, scaly skin
Arsenicum iodatum......................................dry, scaly, itching skin
Bovista............................................................................eczema
Causticum .........................................................raw, burning skin
Dolichos pruriens..........................................intense itching of skin
Fagopyrum esculentum.............................sore, red blotches on skin
Graphites..............................................................rawness of skin
Kali muriaticum........................................................scales on skin
Muriaticum acidum ......................................skin eruptions, itching
Oleander...................................................soreness, chapping skin
Petroleum ......................................................itching skin at night
Pix liquida ....................................................cracked, itching skin
Radium bromatum (12X, 30X, & 1LM potencies)........................
.................................................................all over itching of skin
Rhus toxicodendron .....................................intense itching of skin
Selenium metallicum .......................................itching folds of skin
Sulphur..........................................................itching, burning skin
Urtica urens ................................................. stinging, itching skin**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.Reference image:Skin Irritations.jpg
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SKIN IRRITATIONS AND ITCH RELIEF
agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum album, arsenicum iodatum, bovista, causticum, dolichos pruriens, fagopyrum esculentum, graphites, kali muriaticum, muriaticum acidum, oleander, petroleum, pix liquida, radium bromatum, rhus toxicodendron, selenium metallicum, sulphur, urtica urens. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-2817 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 LYSIMACHIA ARVENSIS WHOLE (UNII: 46883LR90E) (ANAGALLIS ARVENSIS EXTRACT - UNII:46883LR90E) LYSIMACHIA ARVENSIS WHOLE 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 TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 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 WHOLE (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM WHOLE 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 WHOLE (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS WHOLE 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) ORANGE PEEL (UNII: TI9T76XD44) CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY) CARYA OVATA BARK (UNII: X765CF609L) STEVIOL (UNII: 4741LYX6RT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-2817-2 1 in 1 CARTON 12/07/2022 1 59 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 12/07/2022 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-2817) , api manufacture(57955-2817)