Active Ingredient
Benzocaine 20%
Lidocaine 4%
Tetracaine 1%
Blt Skin Cream
FDA Label NDC 73341-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by M2b Pharma Llc for the product Blt Skin Cream (NDC 73341-001). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Topical analgesic
Topical analgesic
Uses
For temporary relief of pain
Warnings
For external use only
Do Not Use
- On wounds or damaged, broken or irritated skin
- In large quantities
- At the same time as other topical analgesics or anesthetics
- If you are currently taking medication to control heart rate or rhythm or if you have any type of heart disease
- If you are allergic to PABA, benzocaine, lidocaine, tetracaine or other sulfonamides (sulfa) type drugs
- If you are under the age of 17
When Using This Product
- Use only as directed. Read and follow all directions and warnings on this label.
- Avoid contact with eyes or mucous membrane
- Do not bandage or cover with any type of clear occlusive dressing
- Do not apply heat (such as heating pad) to area of use
Stop Use And Ask A Doctor If
- If redness or skin irritation is present at application site
- Condition worsens
- Symptoms persist for more than 7 days or clear up and occur again within a few days
- You have any heart conditions
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children over 17 years of age:
- Apply to affected area of pain no more than 3-4 times per day. Do not cover with any occlusive dressing
Do not use on children 17 years and younger without consulting a doctor.
Other Information
- Store at 20-25 degrees C (68-77 degrees F).
- Store away from heat, sunlight, and excessive heat or humidity
Inactive Ingredients
behentrimonium chloride, caprylic/capric triglyceride, cetearyl alcohol, citric acid, dimethyl isosorbide, ethylhexylglycerin, PEG-150 distearate, phenoxyethanol, polyquaternium-37, water
Questions?
1-877-760-1881
Principal Display Panel
Blt-lid (Blt Lid)
Blt-jar (Blt Jar)
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