Acne
FDA Label NDC 55714-2228

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Acne (NDC 55714-2228). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage Section

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

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop 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: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

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

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