Otc - Active Ingredient
ACTIVE INGREDIENTS: Kali bromatum 1X, Natrum bromatum 2X, Niccolum sulphuricum 6X, Sulphur 6X, Hepar sulphuris calcareum 9X.
Acne
FDA Label NDC 57520-0711
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Acne (NDC 57520-0711). 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, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For treatment of the pimples and blemishes of acne.
Warnings
WARNINGS: If symptoms persist or worsen, contact a physician.
If pregnant or nursing, use only under the advice and supervision of a physician.
Keep our of the reach of children.
Safety Sealed for your protection. Do not use if imprinted seal around bottle neck and cap is missing or broken.
CAUTION: Use only as directed.
Do not give to children under six years old or use in the presence of kidney disease.
If skin rash appears, or if nervous symptoms persist, recur frequently, or are unusual, discontinue use and consult a physician.
Dosage & Administration
DIRECTIONS: Take once per day as indicated on chart below. Continue use as long as it is beneficial to your overall condition.
WEIGHT DAILY DOSAGE
50-100 lbs One tablet
100-150 lbs Two tablets
150-200 lbs Three tablets
Over 200 lbs Four tablets
Inactive Ingredient
INACTIVE INGREDIENTS: Lactose, Magnesium stearate.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN.
Indications & Usage
For treatment of the pimples and blemishes of Acne.
Otc - Questions
Manufactured for and dist. by:LOMA LUX LABORATORIESP.O. Box 702418Tulsa, OK 74170-2418Questions? Call us:1-866-LOMALUXMore information? Visit our Web SiteAcnePill.com
Package Label.Principal Display Panel
LOMA LUX
LOMA LUX AcnePill
Dermatologist Developed
TAKE ORALLY
For treatment of the pimples and blemishes of Acne
100 TABLETS
HOMEOPATHIC MEDICINE
Acnepill (Mm1)
* Please review the disclaimer below.
