FDA Label for Blue-emu Lidocaine Dry
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- ADULTS AND CHILDREN OVER 12 YEARS OF AGE
- CHILDREN 12 YEARS OR YOUNGER
- INSTRUCTIONS FOR USE
- STORAGE INFORMATION
- INACTIVE INGREDIENTS
- OTHER
- PRINCIPAL DISPLAY PANEL - 3 PATCH CARTON
Blue-emu Lidocaine Dry Product Label
The following document was submitted to the FDA by the labeler of this product Nfi, Llc. 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.
Active Ingredient
Lidocaine 4%
Purpose
Topical anesthetic
Uses
For the temporary relief of pain.
Warnings
For external use only
Otc - Do Not Use
Do not use if pouch is damaged or opened. Do not use
on large areas of the body or on cut, irritated skin
on open wounds or sensitive skin
for more than one week without consulting a doctor
do not use more than one patch at a time
do not use if you are allergic to lidocaine or any of the inactive ingredients below.
When Using This Product
use only as directed. Read and follow all directions and warnings on this package.
do not allow contact with the eyes
do not bandage or apply local heat (such as heating pads) to the area of use
do not reuse patch.
Stop Use And Ask A Doctor If
condition worsens
rash, itching or skin irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Adults And Children Over 12 Years Of Age
Apply patch to affected area every 8 to 12 hours.
Children 12 Years Or Younger
Consult a physician before use.
Instructions For Use
clean and dry affected area
cut open pouch and remove the patch
remove clear protective liner from the patch
apply to affected area no more than three (3) times per day
leave in place for up to 8 but no more than 12 hours
wash hands thoroughly after applying or removing patch
some individuals may not experience pain relief until several minutes or hours after applying a patch
do not use other local anesthetic products in addition to this patch.
Storage Information
Protect from freezing and excessive heat
Store at 68°-77°F (20°-25°C).
Inactive Ingredients
Crospovidone, emu oil, FD & C Blue #1, menthoxypropanediol, non-latex rubber based adhesive, non-woven backing fabric, polyester film.
Other
DISTRIBUTED BY:
NFI CONSUMER PRODUCTS
501 Fifth Street • Bristol, TN 37620
Toll Free: 800-432-9334
Principal Display Panel - 3 Patch Carton
RELIEF YOU CAN WEAR™
BLUE-EMU®
No Mess!
Odor Free
+ Emu Oil
4% Lidocaine
Dry-Patch
AMERICA'S
#1
ODOR
FREE
EMU OIL FORMULA
3
PATCHES
2.5"X 6"
* Please review the disclaimer below.