FDA Label for Blue Gel Anesthetic
View Indications, Usage & Precautions
Blue Gel Anesthetic 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 |
| Racepinephrine HCl 0.01% | Vasoconstrictor |
Indications & Usage
Uses: External Use Only. Temporarily relieves pain and swelling due to tattooing, permanent makeup or other pain sensitive procedures.
Warnings
Warnings: Avoid contact with eyes.
Do not swallow. Keep out of children's reach.
Do not use if you have
- A history of severe 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.
Otc - Do Not Use
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.
Otc - When Using
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 broken skin and cover with occlusive dressing. Product
is ineffective when applied to intact skin. Wait until anesthetic effect occurs
(2-5 minutes). Remove product before continuing with your procedure.
Inactive Ingredient
Inactive Ingredients: Purified Water, Ethoxydiglycol, Propylene Glycol,
Hydroxyethylcellulose, Sodium Metabisulfite, L-Epinephrine, Diazolidinyl Urea, Disodium
EDTA, Methyl Paraben, Propyl Paraben, Sodium Citrate, Citric Acid, FD&C
Yellow 5, and FD&C Blue 1.
Storage And Handling
Other information: Store in cool dark place or refrigerate.
Discard after expiration date.
Otc - Questions
Questions? Contact distributor on product label for further questions.
Principal Display Panel
NEW & IMPROVED
BLUE
GEL
ANESTHETIC
To reduce pain and swelling during
pain sensitive procedures.
1 oz.
Distributed by: DERMAL SOURCE
Portland, OR 97232
www.dermalsource.com
1-866-568-3223
* Please review the disclaimer below.