Double Fight Kit
FDA Label NDC 78863-1040

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Noon Aesthetics M.r. Ltd for the product Double Fight (NDC 78863-1040). 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 other, active ingredients, purpose, indications & usage, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Indications & Usage

→ Warnings

→ Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel - 50 Gr Kit Carton

Other

Drug Facts:

Developed and Dist. by
NOON Aesthetics
TLV, 62153

Active Ingredients

A - Therapeutic Hydrogel: Salicylic Acid 2%

B - Azelaic Cream: Benzoyl Peroxide 5%

Purpose

Acne treatment

Indications & Usage

Use for the treatment of acne.

Warnings

For external use only

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne at a time.

Do Not Use

on broken skin
on large areas of the skin

Otc - When Using

When using this product apply

only to areas with acne
rinse right away with water if it gets in eyes.

Otc - Stop Use

Stop use and ask a doctor if skin irritation occurs or gets worse.

If going outside, apply sunscreen after using this product. If irritation or sensitivity develop, stop use of both products and ask doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.

Directions

Sensitivity Test for a New User: Apply products sparingly to one or two small affected areas during the ﬁrst 3 days. If no discomfort occurs, follow the directions stated below.

Cleanse the skin thoroughly before applying this product. Cover the entire affected area with a thin layer of Therapeutic Hydrogel (A). After covering the affected area with Therapeutic Hydrogel, apply a thin layer of Azelaic Cream (B) Because excessive drying of the skin may occur start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness of peeling occurs, reduce application to one a day or every other day.

Inactive Ingredients

Therapeutic Hydrogel (A) Aqua, Lactic Acid, Propanediol, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polyacrylate Crosspolymer-6, Isononyl Isononanoate, Ethylhexyl Stearate, Citronellyl Methylcrotonate, Polysorbate 20, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Wheat Straw Glycosides, Cetearyl Alcohol, Cyclopentasiloxane ,Dimethicone, Parfum, Caprylyl Glycol, T-Butyl Alcohol, Sodium Phytate, Xhantan Gum, Sodium Hydroxide, Alcohol, Limonene.

Azelaic Cream (B) Aqua, Azelaic Acid, Azeloglicina, Propylene Glycol, Propanediol, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Alpha-Arbutin, Isononyl Isononanoate, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Dimethyl Isosorbide, Sodium Hydroxide, Cetyl Palmitate, Phenoxyethanol, Xylitol, Dimethicone, Anhydroxylitol, Arachidyl Alcohol, Cetyl Alcohol, Behenyl Alcohol, Xylitylglucoside, Parfum, Citrus Limon Peel Oil, Arachidyl Glucoside, Caprylyl Glycol, Sodium Phytate, Propolis Extract, Glucose, Citric Acid, Sodium Benzoate, Potassium Sorbate, Alcohol.