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FDA Approval

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FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 19, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hydroquinone(40 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Axia Medical Solutions, LLC

Axia Medical Solutions, LLC

929224694

Products1

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

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Product Details

NDC Product Code
68723-143
Route of Administration
TOPICAL
Effective Date
November 21, 2019
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
Code: XV74C1N1AEClass: ACTIBQuantity: 40 mg in 1 g
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
GLYCOLIC ACIDInactive
Code: 0WT12SX38SClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
CAULOSIDE DInactive
Code: 4N5Z068GAZClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
.ALPHA.-TOCOPHEROL SUCCINATE, D-Inactive
Code: LU4B53JYVEClass: IACT
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