Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Acne Pellet
FDA Label NDC 55714-2385
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 55714-2385). 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 otc - keep out of reach of children section, otc - pregnancy or breast feeding section, warnings section, questions, inactive ingredient section, dosage & administration section, otc - purpose section, otc - active ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a doctor before use.
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. If pregnant or breast-feeding, ask a doctor before use.
Questions
newtonlabs.net - Questions ? 800 448-7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 300123
Inactive Ingredient Section
Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
Dosage & Administration Section
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
Otc - Purpose Section
Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.
Otc - Active Ingredient Section
Equal parts of Echinacea 6x, Juglans reg. 6x, Lappa 6x, Taraxacum 6x, Antimon. crud. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium maj. 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.
Indications & Usage Section
Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.
Package Label
Package Label (N015 P01)
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