BREAST CARE- bufo rana, apis mel., asterias rubens, belladonna, bryonia, calc. carb., chamomilla, chimaphila umbellata, cinchona, conium, croton, echinacea, graphites, helonias dioica, lachesis, merc. viv., phellandrium aquaticum phosphorus, phytolacca, pulsatilla, sanguinaria, silicea, hamamelis, ruta, taraxacum liquid 
Newton Laboratories, Inc.

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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Breast Care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Warnings: Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

​If pregnant or breast-feeding​, ask a doctor before use.

WARNINGS SECTION

Warning:​ Keep out of reach of children. Do not use if tamper - evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding​, ask a doctor before use.

QUESTIONS SECTION

newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Questions? 1.800.448.7256

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hamamelis 3x, Phytolacca 3x, Ruta 3x, Taraxacum 3x, Apis mel. 10x, Asterias rubens 10x, Belladonna 10x, Bryonia 10x, Calc. carb. 10x, Chamomilla 10x, Chimaphila umbellata 10x, Cinchona 10x, Conium 10x, Croton 10x, Echinacea 10x, Graphites 10x, Helonias dioica 10x, Lachesis 10x, Merc. viv. 10x, Phellandrium aquaticum 10x, Phosphorus 10x, Phytolacca 10x, Pulsatilla 10x, Sanguinaria 10x, Silicea 10x, Bufo rana 15x.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with1 drop and gradually increase to full dose.

INDICATIONS & USAGE SECTION

Breast Care: Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

PACKAGE LABEL

Product Label

BREAST CARE 
bufo rana, apis mel., asterias rubens, belladonna, bryonia, calc. carb., chamomilla, chimaphila umbellata, cinchona, conium, croton, echinacea, graphites, helonias dioica, lachesis, merc. viv., phellandrium aquaticum phosphorus, phytolacca, pulsatilla, sanguinaria, silicea, hamamelis, ruta, taraxacum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2374
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND15 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 1 mL
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS10 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 1 mL
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA10 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP10 [hp_X]  in 1 mL
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED10 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED10 [hp_X]  in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE10 [hp_X]  in 1 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT10 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY10 [hp_X]  in 1 mL
OENANTHE AQUATICA FRUIT (UNII: N4LEE4Z93J) (OENANTHE AQUATICA FRUIT - UNII:N4LEE4Z93J) OENANTHE AQUATICA FRUIT10 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT10 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT10 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2374-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/17/201701/01/2019
2NDC:55714-2374-259 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/17/201701/01/2019
3NDC:55714-2374-015 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/17/201701/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/17/201701/01/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2374)

Revised: 8/2019
 
Newton Laboratories, Inc.