FDA Label for Zone 2
View Indications, Usage & Precautions
Zone 2 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 |
| Epinephrine | 0.01% | Vasoconstrictor |
Indications & Usage
Uses: Temporarily relieves local pain and swelling on irritated hemorrhoidal tissue or other anorectal disorders.
Warnings
WARNINGS: External use only.
Do not swallow. Keep out of children's reach.
Otc - Do Not Use
Do not use if you have
- A history of sever liver disease or impairment.
- A known allergy or sensitivity to any of the components of this product. If sensitivity occurs, consult a doctor if condition worsens or does not improve in seven days, or clears up and occurs again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered areas.
Do not use if pregnant or nursing. 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.
When Using This Product
- You may notice temporary blanching, skin irritation or sensitivity of the skin where gel is applied
- You may not have pain - avoid sources of heat or injury
- You may have delayed swelling after drug is dissipated
Dosage & Administration
Directions: Sensitivity test advised prior to use.
Apply sparingly to affected area up to four times daily and cover with occlusive dressing. Product is ineffective when applied to intact skin. Wait until anesthetic effect occurs (2-5 minutes). Remove product.
Inactive Ingredient
Inactive Ingredients: Purified Water, Ethoxydiglycol, Propylene Glycol, Hydroxyethylcelluse, Sodium Metabisulfite, Diazolidinyl Urea, Disodium EDTA, Methyl Paraben, Propyl Paraben, and Citric Acid.
Storage And Handling
Other information: Store in a cool dark place or refrigerate. Discard after expiration date.
Otc - Questions
Questions? Contact distributor on product label for further questions.
Principal Display Panel
NDC Code: 80069-012-01
MAXIMUM
Zone 2
TOPICAL ANALGESIC
1 oz.
for use during a pain sensitive procedure
Distributed by: DERMAL SOURCE
Portland, OR 97232
www.dermalsource.com
1-866-568-3223
* Please review the disclaimer below.