FDA Label for Zone 1
View Indications, Usage & Precautions
Zone 1 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 4% | Topical Anesthetic |
Indications & Usage
Indications: Temporarily relieves pain associated with anorectal disorders.
Warnings
Warnings: Do not swallow. Keep out of children's reach.
External use only on intact skin.
Otc - Do Not Use
Do not use if pregnant or breast-feeding.
Do not use if you have seizures or liver disease.
Do not use if you have a known allergy or sensitivity to any
component of this product. If sensitivity occurs, discontinue
use, immediately cleanse skin and seek medical attention. If
condition worsens or if symptoms persist for more than seven
days or clear up and occur again, discontinue use and consult
a doctor. Do not use in large quantities, particularly over raw
surfaces or blistered areas. Avoid contact with eyes. In case of
contact with eyes, rinse immediately with copious amounts of
eyewash and seek treatment by a medical professional. If
accidentally swallowed, get medical attention immediately.
Dosage & Administration
Directions: Sensitivity test advised prior to use.
Apply a moderately thick layer of cream to intact skin. Discontinue use if
sensitivity occurs. Wait for numbness to develop. For thinner skin (eye
area) wait 10-15 minutes. For thicker skin, best results are obtained
after 1 hour of application. Cleanse area thoroughly before procedure.
Inactive Ingredient
Inactive Ingredients: Purified Water, Glyceryl Stearate
(and) PEG 100-Stearate, Petrolatum, Stearic Acid, Cetyl
Alcohol, Xanthan Gum, Glycerol Monostearate, Sodium
Hydroxymethlyglycinate, Triethanolamine, Propyl
Paraben, Methyl Paraben, and BHT.
Storage And Handling
Other information: Store in a cool dark place or
refrigerate. Discard by expiration date.
Otc - Questions
Questions? Contact distributor on product label for further questions.
Principal Display Panel
MAXIMUM
Zone 1
TOPICAL ANALGESIC
7 pH
1/2 oz.
4% Lidocaine Cream
for use before a
pain sensitive procedure
Distributed by: DERMAL SOURCE
Portland, OR 97232
www.dermalsource.com
1-866-568-3223
NDC 80069-014-01
* Please review the disclaimer below.