Acne description, usages, side effects, indications, overdosage, supplying and lots more!

Acne

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Acne

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acne    Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Antimon. crud. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium majus 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrocotyle 15x, Kali brom. 15x, Kali iod. 15x, Ledum 15x, Lycopodium 15x, Nux vom. 15x, Silicea 15x,Sulphur iod. 15x, Zinc. met. 15x, Echinacea 3x, Juglans regia 3x, Lappa 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Gluten-free, non-GMO, beet-derived sucrose pellets.

QUESTIONS

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

Acne

Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum PELLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2229
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Antimony Trisulfide Antimony Trisulfide 15 [hp_X]
Arsenic Cation (3+) Arsenic Cation (3+) 15 [hp_X]
GOLD 15 [hp_X]
MAHONIA AQUIFOLIUM ROOT BARK MAHONIA AQUIFOLIUM ROOT BARK 15 [hp_X]
GIANT PUFFBALL Giant Puffball 15 [hp_X]
Activated Charcoal ACTIVATED CHARCOAL 15 [hp_X]
CAUSTICUM CAUSTICUM 15 [hp_X]
CHELIDONIUM MAJUS CHELIDONIUM MAJUS 15 [hp_X]
Solanum Dulcamara Top Solanum Dulcamara Top 15 [hp_X]
Graphite GRAPHITE 15 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 15 [hp_X]
CENTELLA ASIATICA 15 [hp_X]
POTASSIUM BROMIDE POTASSIUM CATION 15 [hp_X]
Potassium Iodide IODIDE ION 15 [hp_X]
LEDUM PALUSTRE TWIG LEDUM PALUSTRE TWIG 15 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 15 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 15 [hp_X]
SILICON DIOXIDE 15 [hp_X]
SULFUR IODIDE SULFUR IODIDE 15 [hp_X]
Zinc ZINC 15 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
ENGLISH WALNUT English Walnut 3 [hp_X]
ARCTIUM LAPPA ROOT ARCTIUM LAPPA ROOT 3 [hp_X]
TARAXACUM OFFICINALE Taraxacum Officinale 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2229-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-2229-2 56.7 in 1 BOTTLE, GLASS
3 NDC:55714-2229-0 7.08 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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