SOLOX GEL-

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Available from:

Solus Rx, LLC

Therapeutic indications:

Exudate amounts: None, low or moderate. Do not use on wounds with highamount of exudate. Solox Gel™ is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.    Solox Gel™ is contraindicated to persons with allergies to any of the ingredients.

Product summary:

Solox Gel™ is supplied in a 1.5 oz. tube, NDC 72401-025-45. RX ONLY. Made in the USA. Distributed by:  Solus Rx, LLC D'Iberville, MS 39540

Authorization status:

Premarket Notification

Summary of Product characteristics

SOLOX GEL- DRESSING, WOUND, DRUG
SOLUS RX, LLC
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SOLOX GEL - SILVER ANTIMICROBIAL WOUND GEL
PRODUCT DESCRIPTION
Solox Gel™ is a clear amorphous prescription antimicrobial wound gel
containing 55 ppm silver. Solox
Gel™ is designed to provide a moist healing environment and to help
control bioburden.
Solox Gel™ has been shown to inhibit the growth of: • Aspergillus
niger and other fungi • Candida
albicans • E. coli • MRSA • Pseudomonas aeruginosa •
Staphylococcus aureus • Vancomycin-Resistant
Enterococci (VRE)
INDICATIONS
Exudate amounts: None, low or moderate. Do not use on wounds with
highamount of exudate.
Solox Gel™ is indicated for partial and full thickness wounds
including pressure ulcers, venous stasis
ulcers, diabetic ulcers, first and second degree bums, abrasions,
lacerations, skin tears, grafted wounds,
donor sites and surgical wounds.
CONTRAINDICATIONS
Solox Gel™ is contraindicated to persons with allergies to any of
the ingredients.
ADVERSE REACTIONS
There are no known side effects or adverse reactions.
INSTRUCTIONS
DIRECTIONS:
1. Cleanse wound.
2. Evenly apply Solox Gel™ approximately 1/8” to 1/4” thick to
wound area.
3. If appropriate, cover wound with dressing as directed by a
healthcare professional.
4. Repeat as necessary to keep the wound moist.
CHANGING THE DRESSING:
1. Remove secondary dressing, if one is applied.
2. Cleanse the wound bed to remove any remaining Solox Gel™.
3. Re-apply Solox Gel™, following the directions.
WARNING
For external use only. If condition worsens or does not improve within
10-14 days, consult a physician.
Keep this and all similar products out of the reach of children. In
case of deep or puncture wounds,
animal bites, or serious burns consult a physician.
STORAGE
Store Solox Gel™ at room temperature (68 to 77°F (20 to 25°C)).
Avoid storing in light. Although
potency is unaffected by light exposure, Solox Gel™ can darken
slightly with extensive exposure to
light.
HOW SUPPLIED
Solox Gel™ is supplied in a 1.5 oz. tube,