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 2290L-Dis

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

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, Apis mel. 3x, Hamamelis 3x, Hydrastis 3x.

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 dispensing alcohol 20%.

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2290
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA FRUITING BODY	15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X] in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO)	GOLD	15 [hp_X] in 1 mL
MAHONIA AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (MAHONIA AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB)	MAHONIA AQUIFOLIUM ROOT BARK	15 [hp_X] in 1 mL
DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B)	DIEFFENBACHIA SEGUINE	15 [hp_X] in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	15 [hp_X] in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	15 [hp_X] in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	15 [hp_X] in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	15 [hp_X] in 1 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U)	CHAMAELIRIUM LUTEUM ROOT	15 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	15 [hp_X] in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	15 [hp_X] in 1 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	15 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X] in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	15 [hp_X] in 1 mL
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE (UNII: IQV54TN60Y) (HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - UNII:IQV54TN60Y)	HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE	15 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	15 [hp_X] in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	15 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	15 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	15 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	15 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	15 [hp_X] in 1 mL
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT)	LYCOSA TARANTULA	15 [hp_X] in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	15 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	3 [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 BARK	3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-2290-1	29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019
2	NDC:55714-2290-2	59.14 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019
3	NDC:55714-2290-0	0.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/2011	01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2290)

Revised: 10/2019

Document Id: 959be0c8-3e06-50b8-e053-2995a90a7450

Set id: efde854d-ceb4-043b-d1f4-aa576cd94bd9

Version: 3

Effective Time: 20191023

Newton Laboratories, Inc.