Label: CALCAREA FLOUR gel
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Contains inactivated NDC Code(s)
NDC Code(s): 15631-2309-0, 15631-2309-1, 15631-2309-2, 15631-2309-3 - Packager: Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
- 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 March 30, 2016
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- ACTIVE INGREDIENT
- USES
- INDICATIONS
- DOSAGE & ADMINISTRATION SECTION
- WARNINGS
- INACTIVE INGREDIENTS
- STORAGE
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QUESTIONS OR COMMENTS
www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com
Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758
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INGREDIENTS AND APPEARANCE
CALCAREA FLOUR
calcarea flour gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15631-2309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15631-2309-0 1 in 1 CONTAINER 03/30/2016 1 50 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:15631-2309-1 1 in 1 CONTAINER 03/30/2016 2 100 g in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:15631-2309-2 1 in 1 CONTAINER 03/30/2016 3 200 g in 1 CONTAINER; Type 0: Not a Combination Product 4 NDC:15631-2309-3 1 in 1 CONTAINER 03/30/2016 4 500 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/30/2016 Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994) Establishment Name Address ID/FEI Business Operations Rxhomeo Private Limited d.b.a. Rxhomeo, Inc 650833994 manufacture(15631-2309) , label(15631-2309)