FEMININE COMFORT- agaricus musc., arsenicum alb., aur. met., berber. aqui., caladium seguinum, candida albicans, cantharis, conium, graphites, helonias dioica, hydrastis, kali carb., kreosotum, lycopodium, merc. viv., murex purpurea, nat. mur., nitricum ac., pulsatilla, rhus toxicodendron, sepia, sulphur, tarentula hispana, thuja occ., zinc. met., apis mel., hamamelis 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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Feminine 2438L

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with vaginal discomfort such as itching, burning, dryness, irritation, soreness and discharge.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 6 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Hamamelis 6x, Hydrastis 6x, Agaricus musc. 15x, Arsenicum alb.15x, Aur. met. 15x, Berber. aqui. 15x, Caladium seguinum 15x, Candida albicans 15x, Cantharis 15x, Conium 15x, Graphites 15x, Helonias dioica 15x, Hydrastis 15x, Kali carb. 15x, Kreosotum 15x, Lycopodium 15x, Merc. viv. 15x, Murex purpurea 15x, Nat. mur.15x, Nitricum ac. 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sepia 15x, Sulphur 15x, Tarentula hispana 15x, Thuja occ. 15x, Zinc. met.15x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with vaginal discomfort such as itching, burning, dryness, irritation, soreness and discharge.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

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

WARNINGS SECTION

WARNINGS: 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

FEMININE COMFORT 
agaricus musc., arsenicum alb., aur. met., berber. aqui., caladium seguinum, candida albicans, cantharis, conium, graphites, helonias dioica, hydrastis, kali carb., kreosotum, lycopodium, merc. viv., murex purpurea, nat. mur., nitricum ac., pulsatilla, rhus toxicodendron, sepia, sulphur, tarentula hispana, thuja occ., zinc. met., apis mel., hamamelis liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2438
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD15 [hp_X]  in 1 mL
BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB) BERBERIS AQUIFOLIUM ROOT BARK15 [hp_X]  in 1 mL
DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE15 [hp_X]  in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS15 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA15 [hp_X]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP15 [hp_X]  in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE15 [hp_X]  in 1 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT15 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL15 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE15 [hp_X]  in 1 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE15 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY15 [hp_X]  in 1 mL
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE (UNII: IQV54TN60Y) (HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - UNII:IQV54TN60Y) HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE15 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE15 [hp_X]  in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID15 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE15 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR15 [hp_X]  in 1 mL
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA15 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC15 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [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 BARK6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2438-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2438)

Revised: 11/2020
Document Id: b4f501d4-ae0b-a190-e053-2a95a90aae3a
Set id: 9ab4520d-1dd3-7b9f-e053-2a95a90a274f
Version: 2
Effective Time: 20201125
 
Newton Laboratories, Inc.