Label: ALUMINIUM FLUORATUM pellet
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NDC Code(s):
37662-3560-1,
37662-3560-2,
37662-3560-3,
37662-3561-1, view more37662-3561-2, 37662-3561-3, 37662-3562-1, 37662-3562-2, 37662-3562-3, 37662-3562-4, 37662-3563-1, 37662-3563-2, 37662-3563-3, 37662-3563-4, 37662-3564-1, 37662-3564-2, 37662-3564-3, 37662-3564-4, 37662-3565-1, 37662-3565-2, 37662-3565-3, 37662-3565-4, 37662-3566-1, 37662-3566-2, 37662-3566-3, 37662-3566-4, 37662-3567-1, 37662-3567-2, 37662-3567-3, 37662-3567-4
- Packager: Hahnemann Laboratories, 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 July 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE FORMS & STRENGTHS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
- DOSAGE & ADMINISTRATION
- ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALUMINIUM FLUORATUM
aluminium fluoratum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-3561 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM FLUORIDE (UNII: Z77H3IKW94) (ALUMINUM FLUORIDE - UNII:Z77H3IKW94) ALUMINUM FLUORIDE 12 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-3561-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 2 NDC:37662-3561-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 3 NDC:37662-3561-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2023 ALUMINIUM FLUORATUM
aluminium fluoratum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-3560 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM FLUORIDE (UNII: Z77H3IKW94) (ALUMINUM FLUORIDE - UNII:Z77H3IKW94) ALUMINUM FLUORIDE 6 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-3560-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 2 NDC:37662-3560-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 3 NDC:37662-3560-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2023 ALUMINIUM FLUORATUM
aluminium fluoratum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-3566 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM FLUORIDE (UNII: Z77H3IKW94) (ALUMINUM FLUORIDE - UNII:Z77H3IKW94) ALUMINUM FLUORIDE 1 [hp_M] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-3566-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 2 NDC:37662-3566-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 3 NDC:37662-3566-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 4 NDC:37662-3566-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2023 ALUMINIUM FLUORATUM
aluminium fluoratum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-3563 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM FLUORIDE (UNII: Z77H3IKW94) (ALUMINUM FLUORIDE - UNII:Z77H3IKW94) ALUMINUM FLUORIDE 100 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-3563-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 2 NDC:37662-3563-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 3 NDC:37662-3563-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 4 NDC:37662-3563-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2023 ALUMINIUM FLUORATUM
aluminium fluoratum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-3564 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM FLUORIDE (UNII: Z77H3IKW94) (ALUMINUM FLUORIDE - UNII:Z77H3IKW94) ALUMINUM FLUORIDE 200 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-3564-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 2 NDC:37662-3564-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 3 NDC:37662-3564-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 4 NDC:37662-3564-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2023 ALUMINIUM FLUORATUM
aluminium fluoratum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-3567 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM FLUORIDE (UNII: Z77H3IKW94) (ALUMINUM FLUORIDE - UNII:Z77H3IKW94) ALUMINUM FLUORIDE 10 [hp_M] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-3567-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 2 NDC:37662-3567-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 3 NDC:37662-3567-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 4 NDC:37662-3567-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2023 ALUMINIUM FLUORATUM
aluminium fluoratum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-3562 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM FLUORIDE (UNII: Z77H3IKW94) (ALUMINUM FLUORIDE - UNII:Z77H3IKW94) ALUMINUM FLUORIDE 30 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-3562-1 80 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 2 NDC:37662-3562-2 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 3 NDC:37662-3562-3 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 4 NDC:37662-3562-4 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2023 ALUMINIUM FLUORATUM
aluminium fluoratum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-3565 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM FLUORIDE (UNII: Z77H3IKW94) (ALUMINUM FLUORIDE - UNII:Z77H3IKW94) ALUMINUM FLUORIDE 500 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-3565-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 2 NDC:37662-3565-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/10/2023 3 NDC:37662-3565-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 4 NDC:37662-3565-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2023 Labeler - Hahnemann Laboratories, INC. (147098081) Establishment Name Address ID/FEI Business Operations Hahnemann Laboratories, INC. 147098081 manufacture(37662-3560, 37662-3561, 37662-3562, 37662-3563, 37662-3564, 37662-3565, 37662-3566, 37662-3567)
