Indications & Usage Section
Formulated for associated symptoms such as skin changes, discoloration and disomfort of the face, neck and scalp.
Rosacea Liquid
FDA Label NDC 55714-2510
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 Rosacea (NDC 55714-2510). 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 section, otc - pregnancy or breast feeding section, warnings section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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. Sensitive persons begin with 1 drop and gradually increase to full dose.
Otc - Active Ingredient Section
Equal parts of Echinacea 6x, Taraxacum officinale 6x, Arsenicum album 15x, Arsenicum bromatum 15x, Carbo animalis 15x, Causticum 15x, Hydrocotyle asiatica 15x, Kali bromatum 15x, Kali iodatum 15x, Kreosotum 15x, Lycopodium clavatum 15x, Nux vomica 15x, Petroleum 15x, Rhus toxicodendron 15x, Sepia 15x, Sulphur 15x.
Otc - Purpose Section
Formulated for associated symptoms such as skin changes, discoloration and discomfort of the face, neck and scalp.
Inactive Ingredient Section
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
Questions Section
newtonlabs.net – Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
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.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Package Label
Package Label (N063 L01)
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