Other
Drug Facts
Thompson Burn Cream With Lidocaine Cream
FDA Label NDC 73408-985
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Thompson Safety for the product Thompson Burn Cream With Lidocaine (NDC 73408-985). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - 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
Otc - Active Ingredient
Active Ingredients
Benzalkonium Chloride 0.13%
Lidocaine HCI 0.5%
Otc - Purpose
Purpose
Topical antiseptic
Topical analgesic
Indications & Usage
Uses
First aid to help prevent infection in minor cuts, scrapes and burns.
For the temporary relief of pain and itching associated with:
- sunburn
- minor burns
- insect bites
- minor skin irritaion
- cuts
- scrapes
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
- in the eyes
- over large areas of the body or on deep puncture wounds, animal bites, or serious burns
- in large quantities, particularly over raw surfaces or blistered areas
Otc - Stop Use
Stop use and ask a doctor if
- the condition gets worse
- condition clears up and recurs within a few days
- condition persists for more than 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swaallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and childred 2 years and over:
- Children under 2 years:
clean the affected area, apply a small amount not more than 3 to 4 times daily
do not use, consult a doctor
Other Safety Information
Other Information
- store at room temperature (do not freeze)
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
aloe barbadensis leaf juice*, cetearyl alcohol*, aloe vera*, disodium EDTA*, emulsifying wax*, ethyl alcohol*, ethylhexlglycerin*, glycerin*, glyceryl stearate*, methylparaben*, mineral oil, maltodextrin*, paraffin*, propylene glycol*, propylparaben*, purifed water*, PEG-100 stearate*, phenoxyethanol*, stearic acid*, triethanolamine*, white petrolatum*, white wa*x
*may contain
Otc - Questions
Questions or comments?
- 877.506.4291
Package Label.Principal Display Panel
BURN CREAM
WITH LIDOCAINE
BENZALKONIUM CHLROIDE / LIDOCAINE HCL
TOPICAL ANTISEPTIC
ANTISEPTIC AND PAIN RELIEVING CREAM 0.9 g PACKETS
FOR MINOR CUTS, SCRAPES AND BURNS
25 / BOX THOMPSON
SAFETY WORKS BUSINESS THRIVES
* Please review the disclaimer below.
