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Rediburn Burn Gel Skin Protectant

Dosage form: gel
Ingredients: LIDOCAINE 1g in 100g
Labeler: Redicare LLC
NDC Code: 71105-096

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.

Burn Gel

Active Ingredients.........Purpose

Lidocaine 35mg...........Pain Reliever

Uses
  • Protects skin from further damage
  • Cools burns
  • Relieves pain & Itching

Warnings

For External use Only

Do not use

without medical direction on severe burns that cover more than 10% of the body.

When using this product

take care to replace dressings as often as necessary to prevent sticking to the wound.

Stop use and ask a doctor

if irritation persists or worsens.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions
  • Seek medical advice before applying on extreme burns.
  • Apply generous amount of gel to the skin.
  • Repeat as necessary.
  • Cover/wrap burn area if required.

Other information
  • Contents sterile until package opened or damaged.
  • Gel can be rinsed off with water.

Inactive ingredients
  • Propylene glycol
  • Glycerine
  • Silicone emulsion
  • carbomer
  • purified water
  • tea tree oil
  • Aloe

REDIBURN BURN GEL SKIN PROTECTANT 
burn gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-096
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
TEA TREE OIL 
GLYCERIN 
SILICON DIOXIDE 
PROPYLENE GLYCOL 
CARBOMER 940 
Packaging
#Item CodePackage Description
1NDC:71105-096-0210 PACKET in 1 BOX
1NDC:71105-096-013.5 g in 1 PACKET
2NDC:71105-096-0414 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/15/2017
Labeler - Redicare LLC (800149346)
Establishment
NameAddressID/FEIOperations
Redicare LLC800149346manufacture(71105-096)

Revised: 10/2017
 
Redicare LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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