FDA.reportPublic FDA data

KamDoy Skin Emulsion

Manufacturer
Alvix Laboratories
Effective date
2019-09-12
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:22

Label at a glance#

ProductKamDoy Skin Emulsion
Label structure9 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

KamDoy Rx Skin Emulsion is a water-based topical skin care emulsions that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. KamDoy Rx Skin Emulsion contains natural extracts to moisturize the skin.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

KamDoy Rx Skin Emulsion is 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. KamDoy Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

KamDoy Rx Skin Emulsion is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

PRECAUTIONS

PRECAUTIONS SECTION

KamDoy 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. KamDoy 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 KamDoy Rx Skin Emulsion may be continued during anti-infective therapy.
Keep this and other similar products out of the reach of children.

INGREDIENTS

INACTIVE INGREDIENT SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

KamDoy Rx Skin Emulsion is available in:
60mL bottle, 15455-9566-01.
4 - 60mL bottles, 15455-9566-04.


Shake well before using.
Store at room temperature. Do not freeze.


PRESCRIPTION MEDICAL DEVICE:
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

DISTRIBUTED BY
Alvix Laboratories, LLC
6601 Sunplex Drive, Ocean Springs MS 39565
Questions: (888) 526-5449

PACKAGE INSERT

SPL PATIENT PACKAGE INSERT SECTION

KamDoyPIKamDoyPI

KamDoy Rx Skin Emulsion Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KamDoy LabelKamDoy Label

KamDoy Rx Skin Emulsion Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KamDoy cartonKamDoy carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15455-9566-1KamDoy Skin Emulsion60 mL in 1 BOTTLE, SPRAY602
15455-9566-4KamDoy Skin Emulsion4 in 1 CARTON42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15455-9566KAMDOY SKIN EMULSION () [ALVIX LABORATORIES]22 package rows20190913_fe13ed7e-90d3-40cb-85b5-e4b4b6dba0eb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15455-9566-1ML - Milliliter15455-956650ea9433-ec3d-4ca8-aba8-25b89cf2758112017-09-11
15455-9566-4ML - Milliliter15455-9566e9642cd2-a06f-4c46-a367-a9040d51b3ac12019-10-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 ยท 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15455-956615455-9566-1, 15455-9566-4

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.