FDA Label for Live Tula Alcohol Prep Pads Medium Sterile - Isopropyl Alcohol Wipes
View Indications, Usage & Precautions
Live Tula Alcohol Prep Pads Medium Sterile - Isopropyl Alcohol Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Live Tula, Llc. 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.
Description
Drug Facts
Active Ingredient
Isopropyl Alcohol 70% v/v
Purpose
Antiseptic
Use
For preparation of the skin prior to injection to reduce the risk of infection.
Warnings
For external use only.
Flammable: Keep away from fire or flame.
Do not use
With electrocautery procedures.
In or near the eyes.
On mucous membranes.
On irritated or damaged skin.
Stop use and ask a doctor if
Irritation or redness develops.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- Packaging Information
- Package Description:
- Product Information
NDC Code: 84985-700-01
100 prep pads per carton
Each pad contains 0.4 mL
Product Type: Human OTC Drug
Route of Administration: Topical
Otc - When Using
Directions
- Apply topically as needed to cleanse the intended area.
- Use for skin preparation prior to injection:
Apply the product to the skin.
Take the injection or puncture site as the center, and slowly rotate outward in a circular motion.
Repeat application twice.
Ensure the disinfection area is at least 5cm x 5cm.
Allow a contact time of 1 minute for proper disinfection
3.Clean the area before disinfection, if necessary.
Storage And Handling
Other Information
Store at room temperature: 15–30°C (59–86°F).
Do not use the product if the packaging is damaged.
Inactive Ingredient
- Inactive Ingredient
Purified Water (UNII: 059QF0KO0R): 30 mL per 100 mL
Purified Water (used as a solvent).
Otc - Active Ingredient
Active Ingredient/Strength
Isopropyl Alcohol (UNII: ND2M416302): 70 mL per 100 mL
Dosage & Administration
Apply topically as needed to cleanse the intended area. Allow to dry before proceeding with the injection or procedure.
Warnings
Warnings: For external use only. Flammable: Keep away from fire or flame. Do not use: - With electrocautery procedures. - In the eyes, on mucous membranes, or on irritated skin. Stop use and ask a doctor if irritation or redness develops.
Indications & Usage
Indications & Usage: Use for preparation of the skin prior to injection to reduce the risk of infection.
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.
Otc - Purpose
Purpose: Antiseptic
Package Label.Principal Display Panel
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