FDA Label for Lidocaine Hydrochloride

View Indications, Usage & Precautions

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


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