PHLAG SPRAY RX SKIN EMULSION- dressing, wound, drug    
SYNERDERM RX SKIN EMULSION- dressing, wound, drug    
Phlight Pharma

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Phlag Spray Rx Skin Emulsion and SynerDerm Rx Skin Emulsion

DESCRIPTION

Phlag Spray Rx Skin Emulsion & SynerDerm Rx Skin Emulsion are water-based topical skin care emulsions that are indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. Phlag Spray Rx Skin Emulsion & SynerDerm Rx Skin Emulsion contain natural extracts to moisturize the skin.

INDICATIONS & USAGE

Phlag Spray Rx Skin Emulsion & SynerDerm Rx Skin Emulsion are indicated as a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. Phlag Spray Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS

Phlag Spray Rx Skin Emulsion & SynerDerm Rx Skin Emulsion are contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

PRECAUTIONS

Phlag Spray Rx Skin Emulsion & SynerDerm Rx Skin Emulsion is for external use only.

Product should not be used prior to MRI Imaging, as it contains silver nanoparticles that can cause heating during these procedures.

Phlag Spray Rx Skin Emulsion & SynerDerm Rx Skin Emulsion does not contain sunscreen. If the condition does not improve within 10 days, consult a physician. If clinical signs of infection are present, appropriate treatment should be initiated; use of Phlag Spray Rx Skin Emulsion & SynerDerm Rx Skin Emulsion may be continued during anti-infective therapy.

Keep this and other similar products out of the reach of children.

INSTRUCTIONS FOR USE

Shake well before use. Apply a small amount of product in sufficient quantity to cover the affected skin area to be protected, and allow to dry. Reapply up to 4 times per day (or as needed).

INGREDIENTS

Phlag Spray Rx Skin Emulsion contains deionized water, copolymer, vegetable oils from African palms, lidocaine HCl (less than 1%), and silver nanoparticles (as a preservative).

SynerDerm Rx Skin Emulsion contains deionized water, copolymer, vegetable oils from African palms, and silver nanoparticles (as a preservative).

HOW SUPPLIED

Phlag Spray Rx Skin Emulsion is available in 60mL bottles, NDC 70569-025-02.

SynerDerm Rx Skin Emulsion is available in 60mL bottles, NDC 70569-026-02.

Shake well before using.

Store at room temperature. Do not freeze.

Phlight Pharma

998 Robinson Ave. Ste B

Ocean Springs, MS 39564

PHLAG SPRAY RX SKIN EMULSION LABEL
NDC 70569-025-02
Rx Only

60mL
For External Use Only

Phlag Spray Label.jpg

SYNERDERM RX SKIN EMULSION LABEL
NDC 70569-026-02
Rx Only

60mL
For External Use Only

SynerDerm Label.jpg

PHLAG SPRAY RX SKIN EMULSION 
dressing, wound, drug
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:70569-025
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:70569-025-0260 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK14163703/06/2017
SYNERDERM RX SKIN EMULSION 
dressing, wound, drug
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:70569-026
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:70569-026-0260 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK14163703/06/2017
Labeler - Phlight Pharma (080168751)

Revised: 5/2017
Document Id: ad6ed75c-4bb0-4742-a098-583ef94e6086
Set id: 599104b2-06a6-4862-81c0-1abb79c6797f
Version: 1
Effective Time: 20170523
 
Phlight Pharma