Deluo Antimicrobial Wound and Skin Cleanser: Package Insert and Label Information

DELUO ANTIMICROBIAL WOUND AND SKIN CLEANSER-
Solus Rx, LLC

DESCRIPTION

Deluo™ Antimicrobial Wound & Skin Cleanser is a clear hypotonic solution topically applied to skin and wound areas. Deluo™ is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings.

INDICATIONS

Deluo™ Antimicrobial Wound & Skin Cleanser is indicated for management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first and second-degree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

SIDE EFFECTS

In rare cases, a mild stinging sensation may occur. Do not use in case of known hypersensitivity or intolerance to any constituent.

DIRECTIONS

Spray Deluo™ Antimicrobial Wound & Skin Cleanser directly on and around the wound to flush away dirt and debris. Thoroughly clean the wound. If dressing is used, saturate it with Deluo™ and spray directly over the wound. Dressing should extend beyond the wound margins. Flush the wound with Deluo™ and apply a fresh moistened dressing one or more times daily as needed. Soak adherent dressings with Deluo™ to ease removal.

WARNING

Not for injection. Keep out of the reach of children. For external use only.

STORAGE

Store at room temperature in its original sealed container away from direct sunlight and heat. Do not freeze. Do not use after expiration date.

HOW SUPPLIED

Deluo™ Antimicrobial Wound & Skin Cleanser is supplied in a 59.2mL blue spray bottle, NDC 72401-026-60.

RX ONLY.

Made in the USA.

Distributed by:

Solus Rx, LLC

D’Iberville, MS 39540

Deluo™ Antimicrobial Wound & Skin Cleanser label

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DELUO ANTIMICROBIAL WOUND AND SKIN CLEANSER
Product Information
Product Type Item Code (Source) NHRIC:72401-026
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:72401-026-60 59.2 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K160095 05/06/2019
Labeler — Solus Rx, LLC (081242854)

Revised: 05/2019 Solus Rx, LLC

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