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
Drug Facts
Active Ingredients
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 a doctor if condition worsens or persists for more than 7 days or clears up and returns
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away
Directions
- for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
- for children under 2 years of age consult a physician
Inactive Ingredients
aloe vera, germaben II, propylene glycol, purified water
Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com
PAIN RELIEF – Burn Spray
Safetec of America
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Principal Display Panel – 3 Oz. Bottle
NDC 61010-5100-3
Safetec
First Aid
Burn Spray
For Temporary
Pain Relief of
Minor Burns
3 fl. oz. (88.7 ml)
Reorder no. 50104
Principal Display Panel – 2 Oz. Bottle
NDC 61010-5100-4
Safetec
First Aid
Burn Spray
For Temporary
Pain Relief of
Minor Burns
2 fl. oz. (59.1 ml)
Reorder no. 50004
Principal Display Panel – 4 Oz. Bottle
NDC 61010-5100-5
Safetec
First Aid
Burn Spray
For Temporary
Pain Relief of
Minor Burns
4 fl. oz. (118 ml)
Reorder no. 50005
* Please review the disclaimer below.
