FDA Label for Lidocaine Hydrochloride
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- OTC - STOP USE
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL – 0.125 OZ. PACKET
- PRINCIPAL DISPLAY PANEL – 4 OZ. BOTTLE
- PRINCIPAL DISPLAY PANEL - POUCH LABEL
- PRINCIPAL DISPLAY PANEL - 144 BOX LABEL
- PRINCIPAL DISPLAY PANEL - 25 BOX LABEL
Lidocaine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Safetec Of America, 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.
Other
Pain Relief
Drug Facts
Active Ingredient
Lidocaine HCl 2.0%
Purpose
Topical pain relief
Uses
Temporary pain relief for minor burns
Warnings
For external use only
Do Not Use
- In large quantities, particularly over raw or blistered areas
- near eyes, if this happens rinse thoroughly with water
Otc - Stop Use
Stop use and ask doctor if condition worsens or persists for more than 7 days or clears up and occurs again within a few days
Keep Out Of Reach Of Children.
If swallowed get medical help or contact a Poison Control Center right away
Directions
- for adults and children 2 years and older: apply to affected area not more than 4 times daily
- children under 2: do not use, consult a doctor
Inactive Ingredients
aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate
Principal Display Panel – 0.125 Oz. Packet
NDC 61010-5000-0
Safetec
Burn Gel
For Temporary
Pain Relief of
Minor Burns
0.125 oz. (3.7 ml)
Reorder no. 50000
Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215
800-456-7077
www.safetec.com
Principal Display Panel – 4 Oz. Bottle
NDC 61010-5000-4
Safetec
First Aid
Burn Gel
For Temporary
Pain Relief of
Minor Burns
4 fl. oz. (118 ml)
Reorder no. 50001
Principal Display Panel - Pouch Label
Safetec
Burn Gel
0.9 g (1/32 oz.)
Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077
Principal Display Panel - 144 Box Label
NDC 61010-5000-04
Safetec
First Aid
Burn Gel
For Temporary Pain Relief
of Minor Burns
Reorder No. 50007
To reorder:
Call: 1-800-456-7077
Fax: 716-895-2969
Online: www.safetec.com
Principal Display Panel - 25 Box Label
NDC 61010-5000-5
Safetec
First Aid
Burn Gel
For Temporary Pain Relief
of Minor Burns
25 Packets
Each Packet Net. Wt. 0.9gm
* Please review the disclaimer below.