DEFLAME- allantoin cream 
Noon Aesthetics M.R. Ltd

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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DeFlame

Drug Facts

Active Ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

Warnings

For external use only.

Do not use on

  • deep or puncture wounds, animal bites, serious burns.

When using this product

  • avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

Directions

Inactive Ingredients

Aqua, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polydimethylsiloxane, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Polysaccharide, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

Questions or comments?

Visit noonaesthetics.com or call Toll Free 1.833.666.6246

Dist by NOON Aesthetics
TLV, 62153

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

noon
AESTHETICS

DeFlame
SKIN PROTECTANT

+ DERMSHIELD™

50 ml / 1.75 Fl. Oz. e

Principal Display Panel - 50 ml Tube Carton
DEFLAME 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78863-1270
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
LAURETH-4 (UNII: 6HQ855798J)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ACEGLUTAMIDE (UNII: 01J18G9G97)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
SORBITAN TRISTEARATE (UNII: 6LUM696811)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78863-1270-11 in 1 CARTON10/01/2023
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/01/2023
Labeler - Noon Aesthetics M.R. Ltd (600185560)
Establishment
NameAddressID/FEIBusiness Operations
Noon Aesthetics M.R. Ltd600185560MANUFACTURE(78863-1270)

Revised: 9/2023
Document Id: 1fca675a-85d1-4e2a-b47e-ab8aa5f82444
Set id: 2628bd73-0ca9-497b-bcd9-088444cd62be
Version: 1
Effective Time: 20230915
 
Noon Aesthetics M.R. Ltd