Label: ITCH FORMULA- calendula officinalis, apis mellifica, natrum muriaticum, urtica urens, histaminum hydrochloricum, ledum palustre, sulphur, copaiva officinalis, cantharis, croton tiglium, graphites, mezereum, petroleum, rhus venenata, staphysagria, antipyrinum liquid
- NDC Code(s): 43742-1413-1
- Packager: Deseret Biologicals, 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 6, 2018
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ACTIVE INGREDIENTS:
Calendula Officinalis 3X, Apis Mellifica 6X, Natrum Muriaticum 6X, Urtica Urens 6X, Histaminum Hydrochloricum 6X, 12X, 30X, Ledum Palustre 6X, 12X, 30X, Sulphur 8X, Copaiva Officinalis 10X, Cantharis 12X, Croton Tiglium 12X, Graphites 12X, Mezereum 12X, Petroleum 12X, Rhus Venenata 12X, Staphysagria 12X, Antipyrinum 16X.
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to itching, such as hives, itching at night, intolerable scratching, insect bites, poison ivy exposure, skin irritation, dry skin, and lice.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to itching, such as hives, itching at night, intolerable scratching, insect bites, poison ivy exposure, skin irritation, dry skin, and lice.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
ITCH FORMULA
calendula officinalis, apis mellifica, natrum muriaticum, urtica urens, histaminum hydrochloricum, ledum palustre, sulphur, copaiva officinalis, cantharis, croton tiglium, graphites, mezereum, petroleum, rhus venenata, staphysagria, antipyrinum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1413 Route of Administration ORAL 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 3 [hp_X] in 1 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 6 [hp_X] in 1 mL RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] in 1 mL COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT) (COPAIFERA OFFICINALIS RESIN - UNII:1VH544O5AT) COPAIFERA OFFICINALIS RESIN 8 [hp_X] in 1 mL LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 10 [hp_X] in 1 mL CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED 12 [hp_X] in 1 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 12 [hp_X] in 1 mL DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK 12 [hp_X] in 1 mL KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE 12 [hp_X] in 1 mL TOXICODENDRON VERNIX LEAFY TWIG (UNII: Y3VW699H96) (TOXICODENDRON VERNIX LEAFY TWIG - UNII:Y3VW699H96) TOXICODENDRON VERNIX LEAFY TWIG 12 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 12 [hp_X] in 1 mL ANTIPYRINE (UNII: T3CHA1B51H) (ANTIPYRINE - UNII:T3CHA1B51H) ANTIPYRINE 16 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43742-1413-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 12/06/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/06/2018 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1413) , api manufacture(43742-1413) , label(43742-1413) , pack(43742-1413)
