Label: ACNE FREE- antimonium tartaricum, asterias rubens, ferrum metallicum, hepar sulphuris calcareum, kali bromatum, lac defloratum, natrum muriaticum, sanguinaria canadensis, selenium metallicum, sepia, silicea, sulphur, thuja occidentalis liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58066-7001-7 - Packager: Beaumont Bio Med
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 Label Information
Updated January 8, 2015
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
HPUS active ingredients: Antimonium tartaricum, Asterias rubens, Ferrum metallicum, Hepar sulphuris calcareum, Kali bromatum, Lac defloratum, Natrum muriaticum, Sanguinaria canadensis, Selenium metallicum, Sepia, Silicea, Sulphur, Thuja occidentalis. Equal volumes of each ingredient in 10X, 30X, 100X potencies.
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions:
- Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve.
- Before initial dose, depress pump 4-5 times or until primed.
- Consult a physician for use in children under 12 years of age.
Use according to label indications and/or standard homeopathic indications.
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE FREE
antimonium tartaricum, asterias rubens, ferrum metallicum, hepar sulphuris calcareum, kali bromatum, lac defloratum, natrum muriaticum, sanguinaria canadensis, selenium metallicum, sepia, silicea, sulphur, thuja occidentalis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58066-7001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE 10 [hp_X] in 59.2 mL ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS 10 [hp_X] in 59.2 mL IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 10 [hp_X] in 59.2 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 10 [hp_X] in 59.2 mL POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 10 [hp_X] in 59.2 mL SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK 10 [hp_X] in 59.2 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 10 [hp_X] in 59.2 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 10 [hp_X] in 59.2 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 10 [hp_X] in 59.2 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_X] in 59.2 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [hp_X] in 59.2 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 59.2 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X] in 59.2 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58066-7001-7 59.2 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/15/2014 Labeler - Beaumont Bio Med (070624288) Registrant - Beaumont Bio Med (070624288) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(58066-7001)
