FDA Product

MINTOX MAXIMUM STRENGTH

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

MINTOX MAXIMUM STRENGTH

FDA Product Code

17856-5725

Regulatory Information

NDC Product Code

17856-5725

Application Number

M

Marketing Category

C200263

Effective Date

May 23, 2025

Territorial Authority

USA

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

8

Company Information

ManufacturerATLANTIC BIOLOGICALS CORP.

DUNS Number

047437707

Active Ingredients

ALUMINUM HYDROXIDE

Quantity: 400 mg in 5 mL

Code: 5QB0T2IUN0

Class Code: ACTIB

MAGNESIUM HYDROXIDE

Quantity: 400 mg in 5 mL

Code: NBZ3QY004S

Class Code: ACTIB

Quantity: 40 mg in 5 mL

Code: 92RU3N3Y1O

Class Code: ACTIB

Inactive Ingredients

BUTYLPARABEN

Code: 3QPI1U3FV8

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM

Code: K679OBS311

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

ALUMINUM HYDROXIDE

Code: 5QB0T2IUN0

HYDROXIDE ION

Code: 9159UV381P

DIMETHICONE

Code: 92RU3N3Y1O

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