Incontinence
Incontinence 4748L
994cbc8e-a221-1548-e053-2995a90a1f7f
HUMAN OTC DRUG LABEL
Aug 20, 2025
Newton Laboratories, Inc.
DUNS: 788793610
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica , Sabal, Secale, Sepia, Staphysag.,Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (30)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL
INDICATIONS & USAGE SECTION
INDICATIONS & USAGE SECTION
Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.
DOSAGE & ADMINISTRATION SECTION
DOSAGE & ADMINISTRATION SECTION
**Directions:**Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.
OTC - ACTIVE INGREDIENT SECTION
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis canadensis 6x,Aloe 15x, Argentum nitricum 15x, Arsenicum album 15x, Belladonna 15x, Benzoicum acidum 15x, Bryonia 15x, Cantharis 15x, Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium sempervirens 15x, Ignatia amara 15x, Kali phosphoricum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Nitricum acidum 15x, Plantago major 15x, Pulsatilla 15x, Rhus aromatica 15x, Sabal serrulata 15x, Secale cornutum 15x, Sepia 15x, Staphysagria 15x, Stramonium 15x, Thyroidinum 15x, Verbascum thapsus 15x.
OTC - PURPOSE SECTION
OTC - PURPOSE SECTION
Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
OTC - QUESTIONS SECTION
QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA
Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
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. Ifpregnant or breast-feeding, ask a doctor before use
OTC - PREGNANCY OR BREAST FEEDING SECTION
OTC - PREGNANCY OR BREAST FEEDING SECTION
Ifpregnant or breast-feeding, ask a doctor before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.