NDC | 55714-8016-1 |
Set ID | 563e34e4-12ef-0624-998e-3bfcf8711c91 |
Category | HUMAN OTC DRUG LABEL |
Packager | Newton Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- INDICATIONS & USAGE SECTION
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DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 drops by mouth (ages 0 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. Warning: For use as an interim therapy. Seek professional medical intervention for severe injuries, bites or infections.
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
JUST IN CASE
aconitum nap., arnica, arsenicum alb., bryonia, echinacea, ledum, cenchris, crotalus casc. crotalus hor., lachesis, merc. corros., naja, phos., toxicophis, vipera, elaps cor., heloderma liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-8016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 10 [hp_X] in 1 mL Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana 10 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Cation (3+) 10 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 10 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 10 [hp_X] in 1 mL Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig 10 [hp_X] in 1 mL Agkistrodon Contortrix Venom (UNII: 3BKX485ZP0) (Agkistrodon Contortrix Venom - UNII:3BKX485ZP0) Agkistrodon Contortrix Venom 15 [hp_X] in 1 mL Crotalus Durissus Terrificus Venom (UNII: 2XF6I0446G) (Crotalus Durissus Terrificus Venom - UNII:2XF6I0446G) Crotalus Durissus Terrificus Venom 15 [hp_X] in 1 mL Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom 15 [hp_X] in 1 mL Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 15 [hp_X] in 1 mL Mercuric Chloride (UNII: 53GH7MZT1R) (Mercuric Cation - UNII:ED30FJ8Y42) Mercuric Chloride 15 [hp_X] in 1 mL Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom 15 [hp_X] in 1 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 15 [hp_X] in 1 mL Agkistrodon Piscivorus Venom (UNII: X9V1Q8U150) (Agkistrodon Piscivorus Venom - UNII:X9V1Q8U150) Agkistrodon Piscivorus Venom 15 [hp_X] in 1 mL Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom 15 [hp_X] in 1 mL Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom 30 [hp_X] in 1 mL Heloderma Suspectum Venom (UNII: KV57S96367) (Heloderma Suspectum Venom - UNII:KV57S96367) Heloderma Suspectum Venom 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-8016-1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/10/2014 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-8016)