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510(k) Data Aggregation
K Number
K122595Device Name
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
Manufacturer
Date Cleared
2013-05-01
(250 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERMAL LIFE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HYDROPERMEATE™ Topical Emulsion is indicated for use in:
- Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers
- Superficial wounds
- 1st and 2nd degree burns, including sunburns
- Dermal donor and graft site management
- Radiation dermatitis
- Minor abrasions
ANSWER2SKIN™ SUNBURN RELIEF Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor burns, including minor sunburns.
ANSWER2SKIN™ FIRST AID Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor superficial wounds and minor abrasions, including cuts and scrapes.
Device Description
HYDROPERMEATE™ Topical Emulsion consists of approximately 75% purified water, 20% wax (oily) ingredients, and 5% of dissolved ingredients such as triethanolamine sodium alginate, which forms a gel with water. HYDROPERMEATE™ is a prescription product.
ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are topical emulsions consisting of approximately 75% purified water, 20% wax (oily) ingredients, and 5% of dissolved ingredients such as triethanolamine sodium alginate, which forms a gel with water. ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are over-the-counter products.
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