Active Ingredient
Benzalkonium Chloride 0.13% w/w
Lidocaine HCI 4% w/w
Pain Relieving Cleansing Spary Spray
FDA Label NDC 69396-177
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc. for the product Pain Relieving Cleansing Spary (NDC 69396-177). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, uses, when using this product, ask doctor before use, stop use and ask a doctor, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antiseptic
Pain Relieving Spray
Warnings
For External Use Only
Uses
For first aid to help prevent bacterial contamination skin infection and for temporary relief of pain and itching associated with
minor cuts, scrapes, minor burns, sunburn, minor skin irritations.
When Using This Product
- Do not use in or near eyes
- Do not apply over large areas of the body or in large quantities
- Do not apply over raw surfact or blistered area
Ask Doctor Before Use
Ask doctor before use if you have
- Deep or puncture wounds
- Animal Bites
- Serious burns
Stop Use And Ask A Doctor
- If the condition worsens or symptoms persists for more than 7 days or clear up and then occur again within a few days.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
Adults and children 2 years of age and older:
- Clean the affected area
- Spray a small amount of this product to the affected area up to 3 times daily.
- May be covered with a sterile bandage, let dry first
Children under 2 years of age do not use, ask a doctor before use.
Other Information
- Store at controlled room temperature 59°-77°F (15°-25°C)
Inactive Ingredients
Disodium EDTA, Melaleuca alternifolia (tea tree oil), Octoxynol-0, Propylene glycol, Water
Questions Or Comments
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA, LLC.
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
SKU: 4090
* This product is not manufactured or distributed by WellSpring Consumer Healthcare, the distributor of Bactine® Max.
* Please review the disclaimer below.
