FDA Label for Rosacea
View Indications, Usage & Precautions
Rosacea Product Label
The following document was submitted to the FDA by the labeler of this product Newton Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & Usage Section
Rosacea Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.
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
Arsenicum alb. 10x, Arsenicum bromatum 10x, Carbo animalis 10x, Causticum 10x, Hydrocotyle 10x, Kali brom. 10x, Kali iod. 10x, Kreosotum 10x, Lycopodium 10x, Nux vom. 10x, Petroleum 10x, Rhus toxicodendron 10x, Sepia 10x, Sulphur 10x, Echinacea 3x, Taraxacum 3x.
Otc - Purpose Section
Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.
Inactive Ingredient Section
USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
Questions Section
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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