FDA Label for Pro Plus
View Indications, Usage & Precautions
Pro Plus Product Label
The following document was submitted to the FDA by the labeler of this product Dermal Source, 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.
Otc - Active Ingredient
Otc - Purpose
| Active Ingredients (in each cc) | Purpose |
| Lidocaine HCl 5% | Topical Anesthetic |
| Tetracaine HCl 1% | Topical Anesthetic |
Indications & Usage
Uses: External Use Only on Intact Skin. Temporarily relieves pain due to tattooing or other pain sensitive procedures.
Warnings
Warnings:Keep out of children's reach.
Keep out of eyes and mouth. In case of accidental contact with eyes, rinse immediately with copious amounts of eyewash. Seek care by an eye care physician. If accidentally swallowed, get medical help immediately.
Otc - Do Not Use
Do not use:
- If you have a history of severe liver disease or impairment.
- If you have a known allergy or sensitivity to any of the components of this product. If sensitivity occurs, discontinue use and seek medical attention as needed. If condition worsens or does not improve in seven days, or clears up and occurs again within a few days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas.
- If pregnant or nursing.
Dosage & Administration
Directions: Sensitivity test advised prior to use.
Apply sparingly to affected area for 15-30 minutes or until anesthetic effect occurs. Remove and cleanse skin. Repeat as needed up to three times a day.
Inactive Ingredient
Inactive Ingredients: Purified Water, Glycerol Monostearate, Petrolatum, Stearic Acid, Cetyl Alcohol, Hydroxyethylcelluose, Triethanolamine, PEG 100 Stearate, Propyl Paraben, Methyl Paraben, and BHT.
Storage And Handling
Other information: Discard after expiration date. Store in cool, dark place.
Otc - Questions
Questions? Contact distributor on product label.
Principal Display Panel
PREMIUM
PRO PLUS
Topical Anesthetic for use before a pain sensitive procedure
7/8 oz.
Distributed by: DERMAL SOURCE
Portland, OR 97232
www.dermalsource.com
1-866-568-3223
NDC 80069-009-01
NDC Drug Facts - For use by licensed professionals only.
* Please review the disclaimer below.