ACNE: Homeopathic Product Information

ACNE- nickel sulfate hexahydrate, potassium bromide, zinc oxide, calcium sulfide and sulfur tablet, chewable
PLYMOUTH HEALTHCARE PRODUCTS LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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.

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

  • 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.

Keep out of reach of children.

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 information : TAMPER EVIDENT

  • for your protection do not use if blister pack is broken.

Inactive ingredients: Magnesium Stearate, Maltodextrin, Natural Blueberry Flavor, Sucrose.

Questions or Comments?

Call 800-316-9636, Monday through Friday, 9am — 5pm EST or visit www.lomalux.com.

Distributed by Loma Lux Laboratories: 6521 Davis Industrial Parkway, Solon, Ohio 44139 USA

Relieves Acne Symptoms:

Adult/Teen

Back/Body

Hormonal

Rosacea

Promotes Skin Health

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

NDC# 61480-145-63

NATURAL active ingredients

LOMA LUX

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

box labeling
(click image for full-size original)
ACNE
niccolum sulphuricum, kali bromatum, zincum oxydatum, hepar sulphuris calcareum, sulphur. tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61480-145
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICKEL SULFATE HEXAHYDRATE (NICKEL CATION) NICKEL SULFATE HEXAHYDRATE 3 [hp_X]
POTASSIUM BROMIDE (BROMIDE ION) POTASSIUM BROMIDE 1 [hp_X]
ZINC OXIDE (ZINC CATION) ZINC CATION 1 [hp_X]
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 3 [hp_X]
SULFUR (SULFUR) SULFUR 1 [hp_X]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
MALTODEXTRIN
BLUEBERRY
MAGNESIUM STEARATE
Product Characteristics
Color white (off-white with green speckles) Score 2 pieces
Shape ROUND Size 11mm
Flavor BLUEBERRY Imprint Code LL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61480-145-63 3 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 20 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the BOX (61480-145-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 05/01/2016
Labeler — PLYMOUTH HEALTHCARE PRODUCTS LLC (079330314)

Revised: 12/2021 PLYMOUTH HEALTHCARE PRODUCTS LLC

HomeoLabels.com provides trustworthy package insert and label information about marketed homeopathic remedies as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by HomeoLabels.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

We source our database directly from the FDA's central repository of homeopathic remedy labels and package inserts, under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.