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BM BIO28 ICING SUGAR

BM BIO 28 ICING SUGAR

Approved
Approval ID

3e855f3b-c73d-a153-e063-6394a90ad63a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 11, 2025

Manufacturers
FDA

BM Private Limited

DUNS: 645599762

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85816-8028
Product Classification
G
Generic Name
CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2025
FDA Product Classification

INGREDIENTS (16)

SILICA DIMETHYL SILYLATEInactive
Quantity: 0.001 g in 1 g
Code: EU2PSP0G0W
Classification: IACT
CALCIUM SULFATE ANHYDROUSActive
Quantity: 6 [hp_X] in 1 g
Code: E934B3V59H
Classification: ACTIB
POTASSIUM SULFATEActive
Quantity: 6 [hp_X] in 1 g
Code: 1K573LC5TV
Classification: ACTIB
MAGNESIUM STEARATEInactive
Quantity: 0.01 g in 1 g
Code: 70097M6I30
Classification: IACT
CALCIUM FLUORIDEActive
Quantity: 6 [hp_X] in 1 g
Code: O3B55K4YKI
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEActive
Quantity: 6 [hp_X] in 1 g
Code: 70WT22SF4B
Classification: ACTIB
POTASSIUM PHOSPHATE, DIBASICActive
Quantity: 6 [hp_X] in 1 g
Code: CI71S98N1Z
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 6 [hp_X] in 1 g
Code: 660YQ98I10
Classification: ACTIB
SODIUM SULFATEActive
Quantity: 6 [hp_X] in 1 g
Code: 0YPR65R21J
Classification: ACTIB
POVIDONE K30Inactive
Quantity: 0.015 g in 1 g
Code: U725QWY32X
Classification: IACT
SUCROSEInactive
Quantity: 0.973 g in 1 g
Code: C151H8M554
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 6 [hp_X] in 1 g
Code: 451W47IQ8X
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 6 [hp_X] in 1 g
Code: ETJ7Z6XBU4
Classification: ACTIB
TRIBASIC CALCIUM PHOSPHATEActive
Quantity: 6 [hp_X] in 1 g
Code: 91D9GV0Z28
Classification: ACTIB
FERROSOFERRIC PHOSPHATEActive
Quantity: 6 [hp_X] in 1 g
Code: 91GQH8I5F7
Classification: ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEActive
Quantity: 6 [hp_X] in 1 g
Code: HF539G9L3Q
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2015

30g:

label 1

500g:

label 2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2015

check product leaflet

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2015

Sugar
PVP K 30
Magnesium Stearate
Aerosil

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2015

CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2015

check product leaflet

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2015

check product leaflet

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2015

Warnings:

Keep away from children and store at cool and dry place.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2015

Warnings:

Keep away from children and store at cool and dry place.

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