FDA Label for Acne
View Indications, Usage & Precautions
Acne Product Label
The following document was submitted to the FDA by the labeler of this product Plymouth Healthcare Products Llc. 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.
Otc - Active Ingredient
Active ingredients (HPUS*) in each 600mg pill | Purpose** |
Niccolum Sulphuricum 3X HPUS | Pimples, Itching |
Kali Bromatum 1X HPUS | Acne Simplex |
Zincum Oxydatum 1X HPUS | Acne Treatment |
Hepar Sulphuris Calcareum 3X HPUS | Eruption of Pimples |
Sulphur 1X HPUS | Skin Eruptions, Inflammation |
*The letters "HPUS" indicate that these ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States. 1X and 3X are homeopathic dilutions.
Indications & Usage
Uses: For the temporary relief of Acne, Rosacea symptoms. **The claims for this product are based upon traditional homeopathic practice. They have not been reviewed by the FDA.
Warnings
DO NOT USE
|
Ask a doctor before use if
|
Stop use and ask a doctor if
If pregnant, do not use. |
If breast-feeding, ask a doctor before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. |
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions: Adults & Children 50 lbs & Up:
Take ONCE per day as indicated on the chart below according to your weight:
Weight Daily Dosage
50 - 100 lbs ....................... (1) Pills Daily
100 - 150 lbs ..................... (2) Pills Daily
150 - 200 lbs ..................... (3) Pills Daily
Over 200 lbs ...................... (4) Pills Daily
Chew pill & allow to dissolve in the mouth for 1-2 minutes before swallowing. Do not eat or drink anything for 10 minutes after swallowing for maximum effectiveness. Recommended treatment course: 2-4 weeks. Continue using as long as beneficial. Increase dosage by 50% if symptoms do not improve after 1 week.
Other Safety Information
Other information: TAMPER EVIDENT
- for your protection do not use if blister pack is broken.
Distributed by Loma Lux Laboratories: 6521 Davis Industrial Parkway, Solon, Ohio 44139 USA
Inactive Ingredient
Inactive ingredients: Magnesium Stearate, Maltodextrin, Natural Blueberry Flavor, Sucrose.
Otc - Questions
Questions or Comments?
Call 800-316-9636, Monday through Friday, 9am - 5pm EST or visit www.lomalux.com.
Otc - Purpose
Relieves Acne Symptoms:
Adult/Teen
Back/Body
Hormonal
Rosacea
Promotes Skin Health
Other
NATURAL active ingredients
DERMATOLOGIST DEVELOPED
LOMALUX
LABORATORIES
WE TARGET ACNE AT ITS SOURCE - FOR HEALTHY SKIN FROM WITHIN
Just like your daily vitamin, Acne Pill is taken orally to relieve acne symptoms from the inside out. With just one daily dose, Acne Pill's active mineral ingredients help relieve Acne and Rosacea symptoms.
WHEN USED REGULARLY, MAY HELP RELIEVE ACNE SYMPTOMS
NATURE CREATED - DERMATOLOGIST PERFECTED
We use only the finest quality ingredients in our exclusive formulation developed by our dermatologist founder to promote healthy skin from within. A perfect blend of science and nature.
STEROID FREE
LACTOSE FREE
VEGAN/GLUTEN FREE
NATURAL active ingredients
DERMATOLOGIST DEVELOPED
LOMALUX
LABORATORIES
EXCLUSIVE MINERAL TECHNOLOGY PROMOTES SKIN HEALTH
5 Active Mineral Ingredients help relieve acne symptoms of pimples, blackheads, whiteheads, cystic lesions, papules, pustules, redness and inflammation. These inorganic minerals are all natural, earth derived.
CUSTOMIZED DOSAGE ACCORDING TO YOUR WEIGHT - FOR OPTIMAL RESULTS
DERMATOLOGIST DEVELOPED, FOR HEALTHY SKIN FROM WITHIN
STEROID FREE
LACTOSE FREE
VEGAN/GLUTEN FREE
Package Label.Principal Display Panel
NDC# 61480-145-63
NATURAL active ingredients
LOMALUX
LABORATORIES
ACNE • PILL™
HEALTHY SKIN FROM WITHIN™
Relieves Acne Symptoms:
Adult/Teen
Back/Body
Hormonal
Rosacea
Promotes Skin Health
HOMEOPATHIC ORAL MEDICATION
DERMATOLOGIST DEVELOPED
Non - Irritating
Non - Drying
1 DAILY DOSE
Natural Berry Flavor
60 PILLS
* Please review the disclaimer below.