ACNE RELIEF- saponaria, echinacea angustifolia, kalium bromatum, viola tricolor, selenium metallicum, nux vomica, thuja occidentalis, pulsatilla, calcarea picrata, sulphur iodatum, antimonium tartaricum pellet 
HOMEOLAB USA INC.

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.

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DRUG FACTS

ACTIVE INGREDIENTS HPUS

Saponaria officinalis 3X

Echinacea angustifolia 3X

Kalium bromatum 6X

Viola tricolor 3X

Selenium metallicum 4C

Nux vomica 6C

Thuja occidentalis 6C

Pulsatilla 6C

Calcarea picrata 6C

Sulphur iodatum 6C

Antimonium tartaricum 6C

Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

PURPOSE

Helps Relieve Symptoms due to Acne

USES

This is a natural Homeopathic remedy that helps relieve Acne

WARNINGS

If symptoms persist or worsen, discontinue use and contact a health professional.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Keep this and all medications out of reach of children.

DIRECTIONS

Adults: Allow 3 or 4 pellets to dissolve in mouth three times a day for 2 months.  

Children under 12: Take 1/2 the adult dose. Do not exceed the recommended dosage.

OTHER INFORMATION

Do not use if cap seal is broken.

Homeolab USA Inc., 3025 de L'Assomption Blvd., Montreal, QC H1N 2H2   Canada

PRODUCT OF CANADA

CARTON

IMAGE OF CARTONIMAGE OF LABEL

ACNE RELIEF 
saponaria, echinacea angustifolia, kalium bromatum, viola tricolor, selenium metallicum, nux vomica, thuja occidentalis, pulsatilla, calcarea picrata, sulphur iodatum, antimonium tartaricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-0007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SAPONARIA OFFICINALIS ROOT (UNII: RI2K1BMA8B) (SAPONARIA OFFICINALIS ROOT - UNII:RI2K1BMA8B) SAPONARIA OFFICINALIS ROOT3 [hp_X]
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE6 [hp_X]
VIOLA TRICOLOR (UNII: 9Q24RAI43V) (VIOLA TRICOLOR - UNII:9Q24RAI43V) VIOLA TRICOLOR3 [hp_X]
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM4 [hp_C]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_C]
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_C]
CALCIUM PICRATE (UNII: 53D441QVT8) (CALCIUM PICRATE - UNII:53D441QVT8) CALCIUM PICRATE6 [hp_C]
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0) SULFUR IODIDE6 [hp_C]
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE6 [hp_C]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-0007-180 in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/18/2013
Labeler - HOMEOLAB USA INC. (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC.202032533manufacture(60512-0007)

Revised: 10/2013
Document Id: 0653326e-43f6-4a4f-889a-218e05afe37d
Set id: 2a5fb229-c951-40b6-8c99-e38d68049d30
Version: 2
Effective Time: 20131018
 
HOMEOLAB USA INC.