TUMMY ACHES AND GAS- arsenicum album, carbo veg, colocynthis, chamomilla, dioscorea, ipecac, mag. phos, sulphur spray 
UTI AND KIDNEY STONES- apis, berberis vulgaris, bryonia, cantharis, staphysaria, sarsaparilla, urtica urens spray 
NAUSEA, VOMITING AND DIARRHEA- arsenicum album, bryonia, cinchona, colocynthis, ipecac, nux vomica, phosphorous, veratrum album spray 
BUG BITES AND STINGS- aconite, apis, cantharis, carbolicum acidum, hypericum, lachesis, ledum, staphysagria, urtica urens spray 
INFECTED CUTS AND PUNCTURES- arnica, apis, hepar sulph, hypericum, ledum, silicea spray 
CUTS AND SCRAPES- aconite, arnica, calendula, hypericum, silicea spray 
BURNS- arnica, cantharis, calendula, causticum, hypericum, urtica urens spray 
BLUNT TRAUMA- aconite, arnica, calendula, hypericum, ledum, ruta grav. spray 
HEAD INJURY- conite, arnica, belladonna, badiaga, helleborus, hypericum nat sulph spray 
SPRAINS, STRAINS AND FRACTURES- aconite, arnica, calcarea carb. calcarea phosphorica, carbolicum acidum, hepar sulph, hypericum, rhus tox, ruta graveolens, symphytum spray 
MILD EARACHES AND TEETHING- aconite, belladonna, chamomilla, ferrum phosphorica, hepar sulph, plantago, pulsatilla spray 
EYE INJURIES AND INFECTIONS- aconite, arnica, belladonna, euphrasia, gelsemium, hypericum, rhus tox, symphytum spray 
HEADACHES- arnica, apis, bryonia, belladonna, gelsemium, lachesis, lycopodium, magnesia phosphorica, natrum muriaticum spray 
TOOTHACHES AND ABSCESS- arnica, belladonna, calcarea phosphorica, chamomilla, hepar sulph, hypericum, mercurius spray 
Home Sweet Homeopathics

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.

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For symptoms associated with

To be used according to label indications.

Directions:

 Spritz 1 time under the tongue 3 x per day until improvement is seen, dose once each time symptoms return.

Keep out of reach of children.

If no improvement is seen after 7 days or new symptoms develop, discontinue use.

Active ingredients:

listed for each remedy.

Inactive Ingredients:

In reverse osmosis water with less than 1% alcohol.

TUMMY ACHES AND GAS 
arsenicum album, carbo veg, colocynthis, chamomilla, dioscorea, ipecac, mag. phos, sulphur spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARSENIC ACID (UNII: N7CIZ75ZPN) (ARSENIC ACID - UNII:N7CIZ75ZPN) ARSENIC ACID30 [hp_C]  in 30 [hp_C]
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL30 [hp_C]  in 30 [hp_C]
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP30 [hp_C]  in 30 [hp_C]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_C]  in 30 [hp_C]
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA TUBER30 [hp_C]  in 30 [hp_C]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC30 [hp_C]  in 30 [hp_C]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE30 [hp_C]  in 30 [hp_C]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0010-230 [hp_C] in 1 BOTTLE, SPRAY08/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
UTI AND KIDNEY STONES 
apis, berberis vulgaris, bryonia, cantharis, staphysaria, sarsaparilla, urtica urens spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_C]  in 30 [hp_C]
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK30 [hp_C]  in 30 [hp_C]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 30 [hp_C]
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA30 [hp_C]  in 30 [hp_C]
SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SARSAPARILLA30 [hp_C]  in 30 [hp_C]
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED30 [hp_C]  in 30 [hp_C]
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0011-230 [hp_C] in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
NAUSEA, VOMITING AND DIARRHEA 
arsenicum album, bryonia, cinchona, colocynthis, ipecac, nux vomica, phosphorous, veratrum album spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARSENIC ACID (UNII: N7CIZ75ZPN) (ARSENIC ACID - UNII:N7CIZ75ZPN) ARSENIC ACID30 [hp_C]  in 30 [hp_C]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 30 [hp_C]
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK30 [hp_C]  in 30 [hp_C]
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP30 [hp_C]  in 30 [hp_C]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC30 [hp_C]  in 30 [hp_C]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]  in 30 [hp_C]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_C]  in 30 [hp_C]
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0012-230 [hp_C] in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
BUG BITES AND STINGS 
aconite, apis, cantharis, carbolicum acidum, hypericum, lachesis, ledum, staphysagria, urtica urens spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 30 [hp_C]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_C]  in 30 [hp_C]
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA30 [hp_C]  in 30 [hp_C]
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_C]  in 30 [hp_C]
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG30 [hp_C]  in 30 [hp_C]
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED30 [hp_C]  in 30 [hp_C]
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0013-230 [hp_C] in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
INFECTED CUTS AND PUNCTURES 
arnica, apis, hepar sulph, hypericum, ledum, silicea spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_C]  in 30 [hp_C]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG30 [hp_C]  in 30 [hp_C]
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0014-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
CUTS AND SCRAPES 
aconite, arnica, calendula, hypericum, silicea spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 30 [hp_C]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0015-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
BURNS 
arnica, cantharis, calendula, causticum, hypericum, urtica urens spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA30 [hp_C]  in 30 [hp_C]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP30 [hp_C]  in 30 [hp_C]
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0016-230 [hp_C] in 1 BOTTLE08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
BLUNT TRAUMA 
aconite, arnica, calendula, hypericum, ledum, ruta grav. spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 30 [hp_C]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG30 [hp_C]  in 30 [hp_C]
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0017-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
HEAD INJURY 
conite, arnica, belladonna, badiaga, helleborus, hypericum nat sulph spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0018
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 30 [hp_C]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 30 [hp_C]
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) (SPONGILLA LACUSTRIS - UNII:6SZ0G98BHM) SPONGILLA LACUSTRIS30 [hp_C]  in 30 [hp_C]
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0018-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
SPRAINS, STRAINS AND FRACTURES 
aconite, arnica, calcarea carb. calcarea phosphorica, carbolicum acidum, hepar sulph, hypericum, rhus tox, ruta graveolens, symphytum spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 30 [hp_C]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION30 [hp_C]  in 30 [hp_C]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_C]  in 30 [hp_C]
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]  in 30 [hp_C]
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP30 [hp_C]  in 30 [hp_C]
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0019-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
MILD EARACHES AND TEETHING 
aconite, belladonna, chamomilla, ferrum phosphorica, hepar sulph, plantago, pulsatilla spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 30 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 30 [hp_C]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_C]  in 30 [hp_C]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE30 [hp_C]  in 30 [hp_C]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_C]  in 30 [hp_C]
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR30 [hp_C]  in 30 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0020-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
EYE INJURIES AND INFECTIONS 
aconite, arnica, belladonna, euphrasia, gelsemium, hypericum, rhus tox, symphytum spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 30 [hp_C]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 30 [hp_C]
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA30 [hp_C]  in 30 [hp_C]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]  in 30 [hp_C]
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0021-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
HEADACHES 
arnica, apis, bryonia, belladonna, gelsemium, lachesis, lycopodium, magnesia phosphorica, natrum muriaticum spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_C]  in 30 [hp_C]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 30 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 30 [hp_C]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_C]  in 30 [hp_C]
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_C]  in 30 [hp_C]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 30 [hp_C]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE30 [hp_C]  in 30 [hp_C]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0022-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
TOOTHACHES AND ABSCESS 
arnica, belladonna, calcarea phosphorica, chamomilla, hepar sulph, hypericum, mercurius spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59667-0023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]  in 30 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 30 [hp_C]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION30 [hp_C]  in 30 [hp_C]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_C]  in 30 [hp_C]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_C]  in 30 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 30 [hp_C]
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY30 [hp_C]  in 30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59667-0023-230 [hp_C] in 1 BOTTLE, SPRAY08/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/02/2013
Labeler - Home Sweet Homeopathics (078883277)
Establishment
NameAddressID/FEIBusiness Operations
Nichole Michelle Langham078883277manufacture(59667-0010, 59667-0011, 59667-0012, 59667-0013, 59667-0014, 59667-0015, 59667-0016, 59667-0017, 59667-0018, 59667-0019, 59667-0020, 59667-0021, 59667-0022, 59667-0023) , label(59667-0010, 59667-0011, 59667-0012, 59667-0013, 59667-0014, 59667-0015, 59667-0016, 59667-0017, 59667-0018, 59667-0019, 59667-0020, 59667-0021, 59667-0022, 59667-0023) , pack(59667-0010, 59667-0011, 59667-0012, 59667-0013, 59667-0014, 59667-0015, 59667-0016, 59667-0017, 59667-0018, 59667-0019, 59667-0020, 59667-0021, 59667-0022, 59667-0023)

Revised: 8/2013
Document Id: 7c13d9c1-c0ef-4b34-af0c-ac7acc44510f
Set id: c4f89120-4ce8-42df-9626-0437815ac206
Version: 1
Effective Time: 20130802
 
Home Sweet Homeopathics