Acne Tablet, Chewable
FDA Label NDC 61480-145

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Plymouth Healthcare Products Llc for the product Acne (NDC 61480-145). 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 - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

  Drug Facts
 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

Warnings: 

DO NOT USE

  • if you have kidney disease
  • in children under 10 years old
  • children under 50 lbs
  • if pregnant

Ask a doctor before use if

  • you have a known sensitivity to nickel or costume jewelry
  • a known sensitivity to any ingredients in this product

Stop use and ask a doctor if

  • skin rash appears
  • feelings of nervousness occur
  • if condition worsens or does not improve after regular use of this product

    • ​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.