14% Azelaic Acid Acne Cream
FDA Label NDC 84753-056

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Bisutang Biotechnology Co., Ltd. for the product 14% Azelaic Acid Acne (NDC 84753-056). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding inactive ingredient, dosage & administration, warnings, otc - active ingredient, otc - keep out of reach of children, otc - purpose, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Inactive Ingredient

→ Dosage & Administration

→ Warnings

→ Otc - Active Ingredient

→ Otc - Keep Out Of Reach Of Children

→ Otc - Purpose

→ Indications & Usage

→ Package Label.principal Display Panel

Inactive Ingredient

WATER
GLYCERIN
PROPYLENE GLYCOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
DIMETHICONE
HYDROGENATED POLYDECENE
POTASSIUM CETYL PHOSPHATE
POLYACRYLATE CROSSPOLYMER-6
METHYLPROPANEDIOL
HYDROXYACETOPHENONE
POLYACRYLAMIDE
ALLANTOIN
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
C13-14 ISOPARAFFIN
ISOHEXADECANE
XANTHAN GUM
DISODIUM EDTA
SODIUM HYALURONATE
CAPRYLHYDROXAMIC ACID
POLYSORBATE 80
LAURETH-7
DIPOTASSIUM PHOSPHATE
SORBITAN OLEATE
GLYCERYL CAPRYLATE

Dosage & Administration

30g,

Cleanse the skin thoroughly before applying.Apply a thin layer to affected area and gently massage until fully absorbed.Use once or
twice daily,or as directed by a doctor

Warnings

Warnings:For external use only
Avoid contact with eyes and mucous membranes.Mild irritation,redness.or dryness may occur.Stop use and ask a doctor if severe irritation occurs or if symptoms worsen.Do not use on broken or irritated skin or if allergic to any ingredient.lf pregnant or breast-feeding,ask a health professional before use.Keep out of reach of children.If swallowed,get medical help right away.

Otc - Active Ingredient

Azelaic Acid

Otc - Keep Out Of Reach Of Children

Keep out of reach of children,If swallowed,get medical help rightaway

Otc - Purpose

Acne treatment

Indications & Usage

Uses: Helps treat acne and reduce the appearance of blemishes.Helps improve uneven-looking skin tone caused by acne.

Package Label.Principal Display Panel

Label Image (1)

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