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  5. Label Information: Acne

FDA Label for Acne

View Indications, Usage & Precautions

Table of Contents

    1. INDICATIONS & USAGE SECTION
    2. DOSAGE & ADMINISTRATION SECTION
    3. OTC - ACTIVE INGREDIENT SECTION
    4. OTC - PURPOSE SECTION
    5. INACTIVE INGREDIENT SECTION
    6. QUESTIONS
    7. WARNINGS SECTION
    8. OTC - PREGNANCY OR BREAST FEEDING SECTION
    9. OTC - KEEP OUT OF REACH OF CHILDREN SECTION
    10. PACKAGE LABEL

Acne 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



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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