FDA Label for Pharma Care Pro Sterile Prep Swabstick 70% Ipa
View Indications, Usage & Precautions
Pharma Care Pro Sterile Prep Swabstick 70% Ipa Product Label
The following document was submitted to the FDA by the labeler of this product Enviro Specialty Chemicals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts:
Active Ingredients
Isopropyl alcohol 70% v/v
Purposes
Antiseptic
Use
For the preparation of a patient’s skin prior to surgery, injection, venipuncture/phlebotomy procedural sites, to reduce the risk of bacterial and skin infection, when used as directed.
Warnings:
For external use only. Single use only. For Professional Health Care providers use only. Flammable: keep away from fire or flame.
Do not use
• on patients with known allergies to isopropyl alcohol
• for lumbar puncture or in contact with the meninges
• on open skin wounds or as a general skin cleanser
Do not use with electrocautery procedure.
When using this product, keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Direction Of Use
• use with care in premature infants or infants under 2 months of age – these products may cause irritation or chemical burns.
• maximal recommended treatment area using:
• one single swab stick applicator: approx. 2.5 in × 2.5 in (42 cm²)
• three single swab sticks used sequentially: approx. 5.0 in × 5.0 in (150 cm²)
• tear pouch at side notch to reveal applicator handles. Do not touch applicator tip.
• place applicator tip face side down on treatment area.
• completely wet the treatment area with antiseptic
• dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes; use applicator within 2 minutes from opening.
• moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes; use applicator within 2 minutes from opening.
• discard applicators after a single use, along with any unused applicators or remaining solution. It is not necessary to use the entire amount available.
Other Information:
• Store at room temperature • Avoid freezing and excessive heat
Inactive Ingredients
USP purified water
Questions?
• www.escbrands.com • [email protected] • +1 (888) 331-8332 (M to F) 9am to 5pm EST
Packaging
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