Other
Pain Relief
Drug Facts
Lidocaine Hydrochloride Gel
FDA Label NDC 61010-5000
16 label sections · Submitted to the FDA by Safetec Of America, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Lidocaine Hydrochloride (NDC 61010-5000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, otc - stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 doctorif 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 – 0.125 Oz. Packet (Saf0o 0002 01)
Principal Display Panel – 4 Oz. Bottle
NDC 61010-5000-1
Safetec
First Aid
Burn Gel
For Temporary
Pain Relief of
Minor Burns
4 fl. oz. (118 ml)
Reorder no. 50001
Principal Display Panel – 4 Oz. Bottle (Saf0o 0002 02)
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 (Pouch label)
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 (144 Box label)
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
Principal Display Panel (25 Box label)
Principal Display Panel – 10 Packet Box Label
Safetec ®
First Aid
Burn Gel
Quickly soothes pain
caused by minor burns
10 Packets
Each Packet Net. Wt. 0.9g
Made in USA
Reorder No. 50028
Principal Display Panel – 10 Packet Box Label (Saf0o 0004 06)
* Please review the disclaimer below.
